Recent recalls
Every recall in our data posted in the last 60 days (Sep 5, 2026 to Nov 4, 2026): 400 records from CPSC and FDA, all classes. Records without a detail page here link to the official notice.
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Longjili Trading Recalls Pamag Pieeoo Mattresses Due to Risk of Serious Injury or Death from Fire Hazard; Violate Mandatory Standard for Mattress Flammability
The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.
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Harkla Recalls Children’s Sensory Swings Due to Risk of Serious Injury from Fall Hazard
The recalled swings’ ceiling hook can separate from its plate, posing a risk of serious injury from a fall hazard.
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Yinklev Recalls Jocoevol 6-Drawer Dressers Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violate Mandatory Standard for Clothing Storage Units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to…
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RootStim Recalls Minoxidil Hair Regrowth Treatment Bottles Due to Risk of Serious Injury or Death from Child Poisoning; Violate Mandatory Standard for Child-Resistant Packaging
The recalled hair regrowth products contain minoxidil, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The bottle is not…
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HAIARA Power Banks Recalled Due to Risk of Serious Injury or Death from Fire and Burn Hazards; Sold on Amazon.com by Mitrytech
The power bank’s lithium battery can explode and ignite, posing fire and burn hazards to consumers.
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Bodum USA Recalls 5.9 Million French Press Coffee Makers with Replaceable Glass Carafes Due to Risk of Serious Burn Injury
The carafe can unexpectedly break during use if the glass carafe is damaged or cracked, including by use of a metal spoon to stir the coffee, posing a risk of serious…
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DREO Recalls DR-HSH015 Space Heaters Due to Fire and Burn Hazards
The recalled space heaters can overheat and ignite, posing fire and burn hazards.
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NTI and HTP Brand Gas Boilers Recalled Due to Risk of Serious Injury or Death from Fire, Carbon Monoxide (CO) Poisoning and Impact Hazards; Manufactured by Ariston, formerly NTI Boilers
The condensate dish inside the boiler can crack during a delayed ignition, allowing unburned gas to build up inside the sealed cabinet. If the gas ignites, the front…
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Whatever Works Recalls Microwave Grills Due to Risk of Serious Injury or Death from Fire Hazard
The recalled grills can overheat and ignite, posing a risk of serious injury or death from fire hazard.
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SOOWERY Recalls 8-Drawer Fabric Dressers Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violate Mandatory Standard for Clothing Storage Units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to…
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PILLANI Recalls Nursing Pillows Due to Risk of Serious Injury or Death from Suffocation; Violate Mandatory Standards for Nursing Pillows
The recalled nursing pillows violate the mandatory safety standards for nursing pillows because they can obstruct an infant’s breathing, posing a serious risk of injury…
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Fashion Brand Apparel Recalls QZH.DUAO Pajama Sets Due to Risk of Serious Injury or Death from Burn Hazard; Violate Mandatory Standards for Children’s Sleepwear
The recalled children’s pajama sets violate the mandatory safety standards for children’s sleepwear, posing a risk of serious burn injuries.
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Wild West Seed Inc food recall: Wild West Seeds Broccoli Seeds Green Sprouting Calabrese lot #4105
Salmonella
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Sempio Food Services, Inc food recall: Sempio Yellow Peach Official notice ↗
elevated level of lead in canned peaches
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AVID Medical, Inc. medical device recall: Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH31 Official notice ↗
A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.
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Pfizer drug recall: Levoxyl Official notice ↗
Subpotent Drug: confirmed out-of-specification (OOS) assay during stability testing.
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Medline Industries, LP medical device recall: Medline Drape C-Section W/Pouch St 7/Cs Official notice ↗
Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
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Walker Foods, Inc food recall: Marca El Pato Salsa para Enchiladas Official notice ↗
Undeclared salt, garlic, and onions
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Solstice Corporation medical device recall: Xact mole marker for mammography Model/Catalog Number: M15RM Official notice ↗
The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material.
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Medtronic Neuromodulation medical device recall: InterStim SureScan MRI Leads 978A1 & 978B1: LEAD 978A128 ISTM MICRO… Official notice ↗
Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may result in…
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Medtronic MiniMed, Inc. medical device recall: Generic Name: MiniMed Go App Generic Name: MiniMed Go App… Official notice ↗
A software defect in which existing users who had previously configured and enabled the long-acting dose reminder feature in version 1.2.0 or earlier experienced failure…
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Gearharts Fine Chocolates, Inc. food recall: Gearharts Fine Chocolates Official notice ↗
Foreign Object - Broken glass was found in a piece of finished product.
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Evexias Health Solution food recall: Evexias Health Solutions Amino Ultra Official notice ↗
The product is mislabeled and fails to declare fish oil.
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restor3d Inc. medical device recall: Generic Name: restor3d MTP Implant Generic Name: MTP Implant… Official notice ↗
Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization.
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CooperVision, Inc. medical device recall: Generic Name: Softmed Breathables Advanced Toric Official notice ↗
The affected products bear an incorrect statement on the carton packaging indicating that the product is "Indicated for Extended Wear". However, this product is intended…
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Philips North America medical device recall: Philips Smart-hopping 2.0 AP 1.4 GHz Official notice ↗
Unreliable wireless roaming behavior of Smart-hopping 1.0 wireless clients during transport when connecting to Smart-hopping 2.0 infrastructure, resulting in loss of…
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Axonics, Inc. medical device recall: PNE Lead Implant Kit REF: 1701 Official notice ↗
Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users.
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Boston Scientific Cork, Ltd. medical device recall: Direxion Torqueable Microcatheter Official notice ↗
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and…
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Medtronic Navigation, Inc. medical device recall: Medtronic NDI Passive Spheres REF: 8801071 Official notice ↗
Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the…
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Life Technologies Holdings Pte Ltd medical device recall: Ion Torrent Genexus Dx with software Official notice ↗
DNA or RNA sequencing system software has vulnerabilities.
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Beckman Coulter, Inc. medical device recall: Rotor Assy-Sw40 Official notice ↗
Optima XE XPN ultracentrifuge rotors may contain a microstructure defect that can cause rotors to break into two or more pieces (bifurcate) during a centrifugation run,…
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B Braun Medical Inc medical device recall: B Braun SAFSITE Injection Site Official notice ↗
Potential for leakage and backflow at the Safsite valve.
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Philips Ultrasound, LLC medical device recall: Philips Lumify Diagnostic Ultrasound System
Ultrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular access, which may be unavailable…
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Think Surgical, Inc. medical device recall: Think Surgical Square Driver REF: 109126 Official notice ↗
Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during drilling.
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Pritam International Private Limited drug recall: Brush Buddies Official notice ↗
CGMP Deviations
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Abbott medical device recall: Amplatzer Amulet Left Atrial Appendage Occluder Model Numbers 1.… Official notice ↗
Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI).
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Ventec Life Systems, Inc. medical device recall: VOCSN+Pro
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
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Medtronic MiniMed, Inc. medical device recall: CareLink Clinic Official notice ↗
CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calculation logic fails to use custom values entered by…
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El Ruisenor De Mexico, Inc. food recall: Natural Sesame Seeds
various undeclared allergen ingredients (Sesame)
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Techno-path Manufacturing Ltd. medical device recall: Techno-Path Multichem AE Unassayed Level 1 REF:AE621X Official notice ↗
A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional…
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Greiner Bio-One North America, Inc. medical device recall: Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator… Official notice ↗
Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely elevated potassium (K+) and falsely…
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Primal Supplements Group LLC food recall: Primal Herbs
FDA laboratory analysis confirmed that Primal Herbs Volume contains sildenafil not listed on the product label.
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Pacific Coast Producers food recall: Great Value Fruit Cocktail in Fruit Juice from Concentrate NET WT 15… Official notice ↗
Potential contamination with elevated levels of lead.
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Right Value Drug Stores LLC drug recall: Testosterone Cypionate Official notice ↗
Lack of sterility assurance.
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Strides Pharma Inc drug recall: Cinacalcet Tablets Official notice ↗
Failed dissolution specifications
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Gardeners Basics food recall: Gardners Basics brand Waltham 29 Broccoli Sprouting Seeds packaged in…
Salmonella
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Par Health USA, LLC drug recall: Argatroban Injection
Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.
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Pacific Health Sciences Llc food recall: Babies' Magic Tea Official notice ↗
Adulterated (elevated levels of alcohol) infant dietary supplement
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AvKARE drug recall: Amitriptyline Hydrochloride Official notice ↗
Failed dissolution specifications.
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Voila Juice Company food recall: Voila! juice 100% SQUEEZED ORANGE VOILA! OAKLAND Official notice ↗
Product not processed to achieve 5-log pathogen reduction.
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Ascend Laboratories, LLC drug recall: Amlodipine and Olmesartan Medoxomil Tablets Official notice ↗
Out of specification due to dissolution.
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Trader Joe's Company food recall: Trader Joe's Crispy Rice Milk Chocolate Bar Official notice ↗
Undeclared wheat. Product outer label incorrect; contains wrong allergen ingredients.
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Shenzhen Techdow Pharmaceutical Co., Ltd. drug recall: Heparin Sodium Injection Official notice ↗
Lack of Assurance of Sterility
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Viatris, Inc. drug recall: Telmisartan and Amlodipine Official notice ↗
Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications
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Hikma Pharmaceuticals USA INC. drug recall: Abirtega Official notice ↗
Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity.
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EAK Distribution LLC food recall: Heirloom Homegrown Green Sprouting Calabrese Broccoli Sprouts Seed.…
Salmonella.
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Greenwich Rx drug recall: Glutathione Injection
Microbial Contamination of Sterile Products
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BAMAMON Recalls LED Projecting Finger Light Toys Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Toys
None reported.
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Lithonia Lighting Recalls RSX Luminaires with Adjustable Tilt Arm Mountings Due to Risk of Serious Injury from Impact Hazard
The knuckle of the recalled adjustable tilt arm mountings can fail, allowing the luminaire to fall from the mounting arm, posing a risk of serious injury due to impact…
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Costway Recalls Convertible High Chairs Due to Risk of Serious Injury or Death from Entrapment and Fall Hazards; Violate Mandatory Standard for High Chairs
The convertible high chairs violate the mandatory safety standard for high chairs because they do not contain a passive restraint system and a child can slip through the…
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VQQQ Gas Patio Heaters Recalled Due to Risk of Serious Injury or Death from Fire and Burn Hazards
Components on the recalled patio heaters can malfunction, causing gas to be released, posing a risk of serious injury or death from fire and burn hazards.
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FoShanShiNanHaiQuNuoAiTongZhuangShangHang Recalls CIYTI Light-Up Princess Costumes Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Toys
The costumes violate the mandatory safety standard for toys because the button cell batteries can be accessed easily by children, posing a deadly ingestion hazard. If…
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Daring Foods Inc food recall: Made From Plants Official notice ↗
defective packaging; packaging can rupture/explode during cooking.
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Houston Rx LLC drug recall: Tirzepatide/Niacinamide 2mL vial Official notice ↗
Lack of assurance of sterility.
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Medline Industries, LP medical device recall: Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU… Official notice ↗
Discrepancy in the shelf-life of a component
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Deano's Pasta food recall: Deano's Pasta
Undeclared Lobster
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Integrated Medcraft LLC medical device recall: FORWARD Gunshot Wound Kit Official notice ↗
Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad, potentially causing the sterile pad…
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Healthmark Industries Co., Inc. medical device recall: Vinyl Instrument Guards Official notice ↗
Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated.
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Merit Medical Systems, Inc. medical device recall: Scout MD Official notice ↗
The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.
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Intelerad Medical Systems Incorporated medical device recall: IntelePACS Official notice ↗
Following a Chromium-based web-browser, report and displayed images may not match.
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Saratoga Potato Chips LLC food recall: J. HIGGS Loaded Bacon & Cheddar Potato Chips Official notice ↗
Undeclared soy.
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Medline Industries, LP medical device recall: Convenience Kits containing CONMED AirSeal Access Ports ADVANCE… Official notice ↗
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which…
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Medline Industries, LP medical device recall: Medline surgical convenience kits labeled as: CABG AUXILIARY PACK Official notice ↗
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or…
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Howmedica Osteonics Corp. medical device recall: TS Universal Baseplate Finishing Tray Official notice ↗
Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute…
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Cook Incorporated medical device recall: Williams Cystoscopic Injection Needles Official notice ↗
The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing.…
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W L Gore & Associates, Inc. medical device recall: Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis Official notice ↗
The potential for the devices to be mislabeled with the incorrect length.
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SI-BONE, Inc. medical device recall: iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm) Official notice ↗
The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.
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Ferno-Washington Inc medical device recall: Power F2 Powered Fastening System Official notice ↗
Firmware issue may result in intermittent loss or degradation of powered functionality when paired with compatible stretcher. The issue may lead to the system not…
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In2bones USA, LLC medical device recall: REF: P65 ST862 CoLag SCREW Official notice ↗
Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.
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Instrumentation Laboratory medical device recall: HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro…
Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
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Sarnova HC, Llc medical device recall: Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack Official notice ↗
Affected kits were assembled with pediatric nasal cannula instead of the intended adult nasal cannula.
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Made Fresh Salads Inc food recall: Made Fresh brand Black Bean and Corn Salad
Products may be contaminated with Listeria monocytogenes.
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Beckman Coulter, Inc. medical device recall: DxU 840m Iris Official notice ↗
The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check…
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Boston Scientific Corporation medical device recall: NaviFlex LW Pusher Official notice ↗
Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device…
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Neuronetics, Inc. medical device recall: NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil… Official notice ↗
Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.
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Steris Corporation medical device recall: RAPICIDE PA Part A High-Level Disinfectant Official notice ↗
If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may…
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Baxter Healthcare Corporation medical device recall: Likorall Overhead Lifts Product Code: 3121001 Product Description:… Official notice ↗
Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instances where the lift strap…
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Magellan Diagnostics, Inc. medical device recall: LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762 Official notice ↗
In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is…
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Cadwell Industries Inc medical device recall: Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog… Official notice ↗
Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrical stimulation to the patient,…
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Radiometer Medical ApS medical device recall: The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by… Official notice ↗
In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood samples…
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Ethicon, LLC medical device recall: PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture Official notice ↗
Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if…
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Microgenics Corporation medical device recall: MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control Official notice ↗
Vial-to-vial variability in MAS¿ Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, Lot OPRO29061A results in low Parathyroid Hormone (PTH)…
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Becton Dickinson & Co. medical device recall: BD Phoenix Panel NMIC-312. Catalog Number: 449082 Official notice ↗
Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.
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Medtronic Sofamor Danek USA Inc medical device recall: Grafton" DBM and Grafton Plus" DBM contain demineralized human bone… Official notice ↗
Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the…
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Jenavalve Technology Inc. medical device recall: JenaValve Trilogy Delivery Catheter Official notice ↗
Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
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BioFire Diagnostics, LLC medical device recall: Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿… Official notice ↗
Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
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American Health Packaging drug recall: Metoclopramide Tablets Official notice ↗
Presence of Foreign Tablets/Capsules
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Refresco Beverages US Inc food recall: Pur Aqua Sparkling Frost Cherry Limeade 17 oz Official notice ↗
May contain undeclared aspartame.
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Stewart's Shops Corp. food recall: Stewarts Shops Vanilla chocolate Strawberry Ice Cream 1/2 gallon Official notice ↗
Foreign object: May contain pieces of metal
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Zydus Pharmaceuticals (USA) Inc drug recall: Hydrocortisone Sodium Succinate for Injection Official notice ↗
Failed Impurities/Degradation Specifications.
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Teva Pharmaceuticals USA, Inc drug recall: Metoclopramide Tablets Official notice ↗
Presence of Foreign Tablets/Capsules
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Holsum De Puerto Rico, Inc. food recall: Holsum Spinach Flour Tortillas Large Official notice ↗
Undeclared colors (FD&C Blue No. 1 and FD&C Yellow No. 5)
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usOpal Recalls Xalirium Portable Bed Rails Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails
The recalled bed rails violate the mandatory standard for adult portable bed rails because when the bed rails are attached to a bed, users can become entrapped within…
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Primark Recalls 101 Dalmatians Faux Leather Children’s Coin Purses Due to Phthalate Levels and Risk of Ingestion
The coin purses contain higher phthalate concentration levels. Phthalates can be harmful if young children are exposed to sufficient amounts, including through…
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Papablic, of USA Recalls Convertible Bedside Sleepers Due to Risk of Serious Injury or Death from Entrapment, Suffocation and Fall Hazards; Violate Mandatory Standard for Play Yards
The bedside sleepers with play yard extensions violate the mandatory safety standard for play yards because the mattress can become displaced, causing a baby to become…
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Loving Thyself Rocks Recalls Crystal Glass Cups Due to Risk of Serious Injury from Ingestion and Laceration Hazards
Glass can break inside the recalled cups while in use, posing a risk of serious injury from ingestion and laceration hazards.
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HatsanUSA Recalls Blitz Air Rifles Due to Risk of Serious Injury or Death from Projectile Hazard
The recalled air rifles can fire unexpectedly when releasing the bolt before the air rifle is fully cocked, posing a risk of serious injury or death from projectile…
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3M Company Recalls Scotch™ Thermal Laminators Due to Risk of Serious Injury or Death from Fire Hazard
The recalled thermal laminators can overheat, posing a fire hazard.
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Preferred Pharmaceuticals, Inc. drug recall: Lidocaine Ointment USP Official notice ↗
Failed Content Uniformity Specifications
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Pepsico Inc food recall: 28 oz. Gatorade Lemon Lime Official notice ↗
Undeclared Yellow No. 6 and/or Yellow No. 5
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Sierra Nevada Cheese Company, Inc food recall: SIERRA NEVADA CHEESE GRAZIERS RAW MILK SHARP CHEDDAR NET WT. 40 LBS… Official notice ↗
Potential contamination due to E. coli O26:H11.
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Sun Pharmaceutical Industries Inc drug recall: Tretinoin Cream USP Official notice ↗
Failed Impurities/Degradation Specifications
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J&j Innovative Medicine drug recall: Imaavy Official notice ↗
Presence of particulate matter.
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Apothecary Pharma LLC drug recall: Tirzepatide Injection Official notice ↗
Lack of Assurance of Sterility
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LEASA Industries Co., Inc. food recall: LEASA Living Alfalfa Sprouts
Seeds may have been contaminated with E. coli
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WinCo Foods LLC food recall: WinCo Foods Salsa Bean Dip Express Tray is packaged in a foil bottom… Official notice ↗
Bean Dip Trays contains recalled Peperoncini (pepper) which was recalled due to pest issue.
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G L Mezzetta Inc food recall: Mezzetta GOLDEN GREEK PEPERONCINI MEDIUM HEAT 32 FL OZ G.L. MEZZETTA Official notice ↗
Potential contamination with foreign objects: mice.
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Queso Palmita Gp LLC food recall: QUESO PALMITA. Generic Name: Pastel de Queso Official notice ↗
Undeclared milk, cheese declared
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Cipla USA, Inc. drug recall: Fosfomycin Tromethamine Granules for Oral Solution Official notice ↗
Failed Impurities/Degradation Specifications
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Berlin Seeds food recall: Berlin Seeds Alfalfa Sprouting Seeds
Product contains alfalfa seed recalled by the supplier due to potential E. coli and/or Salmonella contamination.
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K.C. Pharmaceuticals, Inc. drug recall: Artificial Tears Sterile Lubricant Eye Drops Official notice ↗
Lack of Assurance of Sterility
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A&p Creations food recall: X10 Natural Enhancement Supplement
Product contains undeclared Sildenafil and Tadalafil.
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Carolina Infusion, LLC drug recall: Tirzepatide 26 Mg/Ml Injectable Official notice ↗
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
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Centric Compounding LLC drug recall: Tri-Immune Boost Official notice ↗
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
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Steris Corporation medical device recall: HexaVue Focus Integration System Official notice ↗
A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could…
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Freshpoint Central Florida, Inc. food recall: Cranberry Chicken Salad Wedge 4.5 oz package in Wedge plastic and… Official notice ↗
The chicken salad sandwich has an improperly declared allergen (egg). While egg is included in the ingredients list on the package label, it is not included in the…
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LeMaitre Vascular, Inc. medical device recall: TufTex¿ Over-the-Wire Embolectomy Catheter Official notice ↗
Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
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Mindray DS USA, Inc. medical device recall: ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM… Official notice ↗
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
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J K Patisserie & Bakery LLC food recall: Lemon Blueberry Loaf packaged in a cardboard box Official notice ↗
Product contains undeclared soybean oil and soy lecithin in the Ingredient Statement. Soy was not declared in the Contains statement.
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Intellijoint Surgical, Inc. medical device recall: Intellijoint Navigation System: Workstation G2 Configured Official notice ↗
A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery,…
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Medtronic MiniMed, Inc. medical device recall: Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump… Official notice ↗
Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test…
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Canon Medical System, USA, INC. medical device recall: Alphenix INFX-8000C/B5 Official notice ↗
Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a…
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Safeguard US Operating LLC medical device recall: Battle Bandage Official notice ↗
Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration and irrigation,…
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GRI Medical & Electronic Technology Co., Ltd. medical device recall: HALYARD Laparoscopy Comprehensive Pack II REF: 49332 Official notice ↗
Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter
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Limitless Cryo Spa LLC medical device recall: Glypto Device Official notice ↗
Lack of 510(k) clearance.
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Polymedco, Inc. / Polymedco Cancer Diagnostic Products, LLC medical device recall: Sediplast Official notice ↗
During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to…
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AVID Medical, Inc. medical device recall: Davinci Trucustom Bundle Official notice ↗
Product may be potentially contaminated with a lubricant used during the manufacturing process.
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Medline Industries, LP medical device recall: Rollator Official notice ↗
The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame…
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Cardinal Health 200, LLC medical device recall: Presource Packs containing Medtronic Microstream Components:… Official notice ↗
Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in disconnecting the adapter…
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Beckman Coulter Inc. medical device recall: DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE Official notice ↗
Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry…
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DRG International, Inc. medical device recall: Sperm Ab ELISA Official notice ↗
Potential for false negative patient results.
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Philips Medical Systems medical device recall: Spectral CT and Spectral CT 7500 RT Official notice ↗
Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system…
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Steris Corporation medical device recall: VERIFY Biological/Integrator Challenge Pack Model/Catalog Number:… Official notice ↗
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles,…
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Onkos Surgical, Inc. medical device recall: Onkos Surgical Inc. My3D Personalized Pelvic Implant Official notice ↗
Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
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The Better Bakehouse Snack Company food recall: Donutful Chocolate Dipped Vanilla Cake Donuts - 7.05oz/10ct.Case…
Undeclared Milk.
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Stryker Sustainability Solutions medical device recall: Bard Ep Xt Decapolar Steerable Official notice ↗
Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate…
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BioSpectra, Inc. drug recall: Biospectra Tris/Tromethamine Official notice ↗
Failed stability specifications
-
Nihon Kohden America LLC medical device recall: Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station Official notice ↗
Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of…
-
Medical Action Industries, Inc. 306 medical device recall: Generic Name: Kit Official notice ↗
An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027.
-
Sweet Sensi food recall: Sweet Sensi Elevated Edibles Hybrid Gum Drops - Passion Guava Kush… Official notice ↗
Staphylococcus aureus detected in product.
-
QUANTUM OPS Inc medical device recall: Brand Name: ADAPTABLE Beach Chair Product Name: Beach Chair surgical… Official notice ↗
Due to a manufacturing issue (inadequate weld) for patient head positioning system.
-
Saint Francis Apizza LLC food recall: Saint Francis Apizza Frozen Pepperoni Pizza Official notice ↗
Undeclared soy allergen: soybean oil and soy lecithin
-
Gias Food Inc. food recall: Lemon Alfredo Fettuccine packed in a yellow plastic sealed bag with…
Contamination with Listeria monocytogenes
-
The Conqueror Recalls Avengers Medals Due to Risk of Serious Injury or Death from Magnet Ingestion; Violate Mandatory Standard for Magnets
The recalled medals violate the mandatory safety standard for magnets because the high-powered magnets may detach, posing a deadly ingestion hazard to children. When…
-
Snow Peak Recalls Propane Fireplace Inserts and Lava Rocks Due to Risk of Serious Injury or Death from Burn and Fire Hazards
The fireplace's lava rocks can ignite and explode when heated in the propane insert, posing a risk of serious injury or death from burn and fire hazards.
-
Romorgniz Recalls Six-Drawer Dressers Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violate Mandatory Standard for Clothing Storage Units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to…
-
Pacearth Direct Recalls PACEARTH Swing Seats Due to Risk of Serious Injury from Fall Hazard
The seats, metal carabiners or quick links, or webbing straps of the recalled swing seats can break during use, posing a risk of serious injury due to fall hazard.
-
ONTHEWEI Recalls Baby Bath Seats Due to Risk of Serious Injury or Death to Children from Drowning; Violate Mandatory Standard for Infant Bath Seats
The recalled bath seats violate the mandatory standard for infant bath seats because they are unstable and can tip over while in use, posing a risk of serious injury or…
-
Decathlon America Recalls Van Rysel GRVL AF Bicycles Due to Risk of Serious Injury or Death from Crash Hazard
The recalled bicycles' front lock nut can loosen during use, causing the front wheel to dislodge or loosen over time, posing a crash hazard.
-
DR Power Equipment Recalls Pilot and Premier Trimmer Mowers Due to Risk of Serious Injury or Death from Fire and Burn Hazards
Grass and debris can accumulate in the trimmer mowers and ignite, posing a risk of serious injury or death from fire and burn hazards.
-
Giant Bicycle Recalls LED-Light Keys Included with SureLock Bike Lock Sets Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Consumer Products with Button Cell Batteries
The LED-light key that was included with certain SureLock Bicycle Lock sets violates the mandatory safety standard for consumer products with button cell and coin…
-
Apotex Corp. drug recall: Paroxetine Extended-Release Tablets Official notice ↗
Failed dissolution specifications.
-
SLT Foods Inc. food recall: Khazana The Treasure Spice Magic Fennel Candy Official notice ↗
Undeclared Yellow 5 & 6, Red 3, and Blue 1
-
Galil Importing Corp food recall: Lior brand Cinnamon Ground Seasoning Official notice ↗
Product contains elevated levels of lead.
-
Toji Co. food recall: Cloud Cafe branded Collagen Milk Official notice ↗
Undeclared allergen ingredient (fish)
-
Aurolab Trust drug recall: FOCUS PI Hypromellose 0.7% Formula Official notice ↗
Lack of Assurance of Sterility
-
Par Health USA, LLC drug recall: Buprenorphine Hydrochloride Official notice ↗
Crystallization
-
Pacific Health Sciences Llc food recall: Organiccs Absolutely Pure Official notice ↗
Undeclared shellfish (crab shell): source of ingredient Glucosamine sulfate
-
Ajanta Pharma USA Inc drug recall: Ranolazine Extended-Release Tablets Official notice ↗
Failed Dissolution Specifications: below specification
-
Todd's Seeds LLC food recall: Todd's Seeds Alfalfa Sprouting Seeds
Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall)
-
SV Labs Toronto Corporation drug recall: Benzoyl Peroxide Wash Official notice ↗
Microbial contamination of topical product.
-
Philips North America Llc medical device recall: Philips Medical Systems Technologies Ltd. Spectral CT 7500 Official notice ↗
The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may…
-
Philips North America medical device recall: Ingenia Blue Seal SE and Blue Seal XE Official notice ↗
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If…
-
Medline Industries, LP medical device recall: Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories
Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potentially leading to…
-
Noxbox Ltd medical device recall: NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I Official notice ↗
Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.
-
Lmsi, LLC food recall: Kofinas Garlic Mediterranean Infused Extra Virgin Olive Oil Official notice ↗
Product contains garlic essential oil not approved for culinary use
-
TerSera Therapeutics LLC drug recall: Zoladex Official notice ↗
Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.
-
Draeger, Inc. medical device recall: VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310…
Potential cracks in the hose, which could lead to leakage or the hose falling off.
-
Olympus Corporation of the Americas medical device recall: Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number:… Official notice ↗
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese…
-
Cardinal Health 200, LLC medical device recall: Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets:… Official notice ↗
The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can…
-
American Contract Systems Inc medical device recall: Medical convenience kits containing BD CliniClean Pericare Wipes… Official notice ↗
Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing…
-
American Nitrile Operations Llc medical device recall: Brand Name: Performance Pro Product Name: Performance Pro… Official notice ↗
Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious…
-
Amneal Pharmaceuticals, LLC drug recall: Estradiol Gel Official notice ↗
Defective Container; packets were found to be either empty or partially full.
-
Admiral Beverage Corporation food recall: 7up Tropical beverage Official notice ↗
Product may contain undeclared sugar.
-
Shanghai United Imaging Healthcare Co., Ltd. medical device recall: Computed Tomography X-ray System Official notice ↗
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged…
-
Volcano Corp medical device recall: Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v Official notice ↗
Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
-
Siemens Healthcare Diagnostics, Inc. medical device recall: Atellica CH Revised C-Reactive Protein Official notice ↗
The potential for falsely elevated results.
-
Heraeus Medical GmbH (Dental Division) medical device recall: PALACOS R pro 40 Official notice ↗
Potential for monomer liquid leakage.
-
Custom Interventional Pain Management, LLC medical device recall: Brand Name: Ferndale Laboratories Official notice ↗
Due to manufacturing issues with the liquid skin adhesive containing in surgical convenience trays/kits.
-
Micro Therapeutics, Inc. medical device recall: Pipeline Flex Embolization Device with Shield Technology REF… Official notice ↗
Due to incorrect label/product dimensions. Product is supposed to be 3.00 mm in diameter, but unit is packaging was a 2.50 mm in diameter.
-
ASP Global, LLC. medical device recall: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF Official notice ↗
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated…
-
Wright Medical Technology, Inc. medical device recall: CHARLOTTE CLAW Screw Official notice ↗
Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used…
-
Percussionaire Corporation medical device recall: Intrapulmonary Percussive Ventilation Official notice ↗
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled…
-
Salata Dressings, LLC food recall: Salata Salad Kitchen Jalapen¿o Avocado Dressing. Keep Refrigerated.…
This recall was initiated due to potential Salmonella contamination in diced jalape¿no received from the supplier
-
Penumbra Inc. medical device recall: Brand Name: Penumbra System Official notice ↗
Due to manufacturing issues reperfusion catheters may fracture.
-
Bard Peripheral Vascular Inc medical device recall: EnCor EnCompass Breast Biopsy and Tissue Removal System Console Official notice ↗
Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure…
-
Tandem Diabetes Care, Inc. medical device recall: Brand Name: Tandem t:slim mobile application Product Name: t:slim… Official notice ↗
A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott…
-
Beckman Coulter Mishima K.K. medical device recall: Systems/units containing affected software/SQL BECKMAN COULTER… Official notice ↗
Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when…
-
Karl Storz Endoscopy medical device recall: HOPKINS Telescope 30¿ Official notice ↗
Due to incorrect inside packaging label for eyepiece.
-
Illumina, Inc. medical device recall: NovaSeq 6000Dx including DRAGEN Server Official notice ↗
Retrospectively reported correction for an instrument intended for targeted sequencing of DNA libraries from human genomic DNA used with in vitro diagnostic assays has a…
-
Merit Medical Systems, Inc. medical device recall: Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam Official notice ↗
Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile…
-
Olympus Corporation of the Americas medical device recall: Olympus Tripp-Lite P580-025 25ft DisplayPort Cable Official notice ↗
While in the high-power operating mode, a video dropout/blackout may occur when using a particular accessory cable.
-
Spectrum Medical Srl medical device recall: Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard… Official notice ↗
Due to blood-to-glycol leak in the heat exchanger.
-
Alere San Diego, Inc. medical device recall: McKesson CONSULT hCG Urine Cassette Official notice ↗
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
-
Coco G's Snack Foods, Inc. food recall: Coco G's Courmet Flaming Cheddar Hots
Potential Salmonella contamination.
-
HeartSine Technologies Ltd medical device recall: HeartSine samaritan PAD Official notice ↗
Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.
-
Agrish Reannounces and Expands Recall of Adult Portable Bed Rails Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails; Additional Units Added
The recalled bed rails violate the mandatory standard for adult portable bed rails because when the bed rails are attached to a bed, users can become entrapped within…
-
Golden Resale Recalls Portable Camping Showers Due to Risk of Serious Injury or Death from Fire Hazard
The recalled camping showers' immersion heaters can quickly ignite when they are partially or completely out of water, posing a risk of serious injury or death from a…
-
Dollar Tree Stores Recalls Electric Balloon Pumps Due to Burn Hazard
The recalled electric balloon pumps can overheat, posing a burn hazard.
-
Kobayashi Recalls Rechargeable Hand Warmers Due to Risk of Serious Injury from Fire and Burn Hazards
The lithium-ion battery and electrical components in the recalled hand warmers can overheat and ignite, posing a risk of serious injury from fire and burn hazards.
-
Walmart Recalls Over 4.4 Million Expert Grill Brushes Due to Ingestion Hazard
Small metal wire bristles can detach from the brushes and stick to the grill or food, posing an ingestion hazard and risk of serious internal injuries that could require…
-
Gobi Heat Recalls Rechargeable Hand Warmers Due to Risk of Serious Injury from Fire and Burn Hazards
The lithium-ion battery and electrical components in the recalled hand warmers can overheat and ignite, posing a risk of serious injury from fire and burn hazards.
-
GBYMIUY Recalls Magnetic Stick Figure Toy Sets Due to Risk of Serious Injury or Death from Magnet Ingestion; Violate Mandatory Standard for Toys
The magnetic stick figure toy sets violate the mandatory standard for toys because they can liberate loose high-powered magnets posing an ingestion hazard to children.…
-
Designs Direct Recalls Cupcakes and Cashmere Brand Three-Light Floor Lamps, Due to Risk of Serious Injury from Fire and Burn Hazards
When plugged in or switched on, the lamp cord or internal wiring can smoke, melt, spark, overheat or ignite, posing a risk of serious injury from fire and burn hazards.
-
LLK Trading Recalls Mochi Malrang Mystery Dumpling Toys Due to Risk of Serious Injury or Death from Water Bead Ingestion; Violate Mandatory Standard for Toys
The mystery dumpling toys violate the mandatory safety standard for toys because the water beads inside the dumplings expand larger than permitted, posing a deadly…
-
YunHeng Recalls LandTale Bed Rails Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails
The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed rail and the…
-
Gazelle USA Recalls Urban Arrow Cargo Electric Bikes Due to Fall Hazard
The front bolt in the seat post clamping mechanism can break, causing the seat to become loose, posing a fall hazard.
-
ABC Trading Recalls Squishy Toys Due to Risk of Serious Injury or Death from Water Bead Ingestion; Violate Mandatory Standard for Toys
The squishy toys violate the mandatory safety standard for toys because the water beads inside the toys expand larger than permitted, posing a deadly ingestion hazard.…
-
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company drug recall: Clear Eyes Redness Relief Official notice ↗
Lack of Assurance of Sterility
-
WWF Operating Company food recall: So Delicious Dairy Free Salted Caramel Cluster Cashewmilk Official notice ↗
Product may contain foreign material: small stones and other hard objects.
-
WFM Purchasing, LP food recall: Fromagerie Coop de Mean Cabricharme and Belgium Cabricharme Shelf…
Undeclared Egg Allergen
-
Kwok Shing, Inc. food recall: American Ginsengs. PRODUCT OF WISCONSIN. NET WT: 4 oz. NET WT. 8 oz Official notice ↗
Potential contamination with pesticides.
-
Gias Food Inc. food recall: Lemon Alfredo Fettuccine packed in a yellow plastic sealed bag with…
Contamination with Listeria monocytogenes
-
Evergreen Fresh Sprouts LLC food recall: Evergreen Fresh Sprouts LLC
Salmonella
-
Macleods Pharmaceuticals Limited drug recall: Olanzapine Tablets Official notice ↗
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
-
Philips North America Llc medical device recall: Achieva 1.5T Official notice ↗
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements…
-
CooperVision, Inc. medical device recall: Brand Name: Pearle Vision 1 day Product Name Official notice ↗
A small number of lenses within the affected lot are of the incorrect power.
-
AVID Medical, Inc. medical device recall: Halyard IV START KIT NON-STERILE Official notice ↗
Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator.
-
Amneal Pharmaceuticals of New York, LLC drug recall: Exenatide Injection Official notice ↗
Defective Delivery System: Possibility of no medication in the prefilled pen.
-
AVID Medical, Inc. medical device recall: Halyard IV START KIT NON-STERILE
Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.
-
New York Embroidery Studio, Inc. medical device recall: New York Embroidery Studio Trinity Non-Surgical Isolation Gown Official notice ↗
Gowns do not consistently meet the minimum liquid-barrier performance required.
-
Biomerieux Inc medical device recall: Vitek 2 Ast-N461 Test Kit Official notice ↗
The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a…
-
Abiomed, Inc. medical device recall: Automated Impella Controller Official notice ↗
Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and…
-
Intervascular, Sas medical device recall: Cardioroot Woven Collagen Coated Vascular Graft Official notice ↗
Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).
-
Medline Industries, LP medical device recall: Medline Convenience Kits: 1) PEDS SINUS PACK Official notice ↗
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks…
-
Medline Industries, LP medical device recall: Medline convenience kits containing Healthmark Instrument Channel… Official notice ↗
Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential…
-
DeRoyal Industries Inc medical device recall: REF: 81-030415 Myocardial Probe Non-Pyrogenic Official notice ↗
Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
-
United Sugar Producers and Refiners food recall: Light Brown Sugar Official notice ↗
Potential Wheat Kernel contamination.
-
Sterling Pharmaceutical Services LLC drug recall: AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Official notice ↗
Lack of Assurance of Sterility
-
Cardinal Health 200, LLC medical device recall: Presource Convenience Kits: 1) KIT Official notice ↗
The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in…
-
Philips Ultrasound, LLC medical device recall: Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234 Official notice ↗
Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow…
-
Elegant Foods, LLC food recall: Pecorino Toscano D.O.P. STAGIONATO cheese wheels. Product of Italy.… Official notice ↗
Potential Listeria contamination from dripping condensation in cooler.
-
Fresenius Medical Care Renal Therapies Group, LLC medical device recall: CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and… Official notice ↗
Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.
-
Maquet SAS medical device recall: PowerLED 300 Concealed Lighting System Official notice ↗
The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury.
-
Seaspine Orthopedics Corporation medical device recall: SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head Official notice ↗
The proximal thread depth of the spinal device is out of design specification.
-
Boston Scientific Corporation medical device recall: Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5
Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure…
-
Baxter Healthcare Corporation medical device recall: Brand Name: VOLARA System Product Name: VOLARA Official notice ↗
Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing…
-
Ventec Life Systems, Inc. medical device recall: HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870… Official notice ↗
Labeling; Oxygen Cylinders do not contain required medical gas labeling
-
CooperSurgical, Inc. medical device recall: Inca
Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure,…
-
Midmark Corporation medical device recall: Midmark IQvitals Zone Official notice ↗
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
-
Olympus Corporation of the Americas medical device recall: Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11 Official notice ↗
Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,
-
SHANTOU Qiwei industrial Co., Ltd drug recall: Menow Sunscreen Pressed Powder Spf35 Pa+++ Official notice ↗
cGMP Deviations
-
Olympus Corporation of the Americas medical device recall: Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog… Official notice ↗
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
-
Baxter Healthcare Corporation medical device recall: Pro+ Mrs Surface For Versacare Official notice ↗
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or…
-
Heidelberg Engineering GmbH medical device recall: Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with… Official notice ↗
Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a result.…
-
Criticare Technologies, Inc. medical device recall: nGenuity Patient Monitor with Capnography Official notice ↗
Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.
-
Becton, Dickinson and Company medical device recall: ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code:… Official notice ↗
Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.
-
ABC Trading Recalls Light-Up Children’s Toys Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Toys
The recalled children’s toys violate the mandatory standard for toys because they contain button cell batteries and the compartments that hold the batteries can be…
-
Love To Dream Recalls Portable Sleep Machines Due to Risk of Injury from Fire and Burn Hazards
The lithium-ion battery in the recalled portable sleep machines can overheat if the charger is not compatible with the unit, posing a risk of injury from fire and burn…
-
INMO International Technology Limited Recalls INMO Air3 Smart Glasses Due to Risk of Serious Injury or Death from Burn Hazard
The left temple of the recalled smart glasses can overheat during extended use, posing a risk of serious injury or death due to burn hazard.
-
Style Homeware Recalls Emerspring Mattresses Due to Risk of Serious Injury or Death from Fire Hazard; Violate Mandatory Standard for Mattress Flammability
The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.
-
Yuyitop Recalls Aitjunz 8-Drawer Dressers Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violate Mandatory Standard for Clothing Storage Units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to…
-
Xinan Home Recalls WinxMatrs Mattresses Due to Risk of Serious Injury or Death from Fire Hazard; Violate Mandatory Standard for Mattress Flammability
The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.
-
NEWDERY Power Banks Recalled Due to Fire and Burn Hazards; Risk of Serious Injury; Sold on Amazon
The lithium-ion battery in the power banks can explode or ignite, posing fire and burn hazards to consumers.
-
The Blue Cactus Company Reclining Chair Battery Packs Recalled Due to Fire and Burn Hazards; Sold on Amazon
The lithium-ion battery in the recalled battery packs can overheat, posing fire and burn hazards to consumers.
-
Hyperfuels Recalls Methanol and Ethanol Fuel Containers Due to Risk of Serious Injury or Death from Child Poisoning and Flame Jetting; Violates Multiple Federal Safety Standards
The recalled fuel containers violate the mandatory safety standards for portable fuel containers because they lack flame mitigation devices required under the Portable…
-
5Color Recalls Children’s Bicycle Helmet and Pads Sets Due to Risk of Serious Injury or Death from Head Injury; Violate Mandatory Standard for Bicycle Helmets
The helmets in the recalled sets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the impact attenuation, retention…
-
ZCK01 Recalls Kesyup Mattresses Due to Risk of Serious Injury or Death from Fire Hazard; Violate Mandatory Standard for Mattress Flammability
The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.
-
Optimus Inc. d/b/a/ Markys Caviar food recall: Mon Sire Brie
The firm was notified by their Brie Cheese supplier that sample results revealed the presence of Listeria monocytogenes.
-
Frutas y Hortalizas del Sur S.A. food recall: Organic Triple Berry Blend Strawberries
Potential E. coli O145:H28 Contamination
-
Foods Alive Inc. food recall: Foods Alive organic moringa leaf powder
Potential Salmonella contamination
-
Pfizer drug recall: Dopamine HCl Inj Official notice ↗
Lack of Assurance of Sterility
-
Tiffany Food Corp food recall: Hexing Haw Balls candy Official notice ↗
Unapproved dye Ponceau 4R
-
Inventia Healthcare Limited drug recall: Chlorthalidone Tablets Official notice ↗
Failed Dissolution Specifications
-
Best Friends Bakery, LLC food recall: PUMPKIN SPICE NO BAKE COOKIE NET WT 3.5 oz. INGREDIENTS: WHOLE GRAIN… Official notice ↗
Peanuts & Eggs. The firm list peanuts in the ingredient statement but omitted them from the contain statement. They also have eggs listed in the contain statement but…
-
Sun Pharma /taro drug recall: Lidocaine Ointment USP Official notice ↗
Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
-
Panorama Produce Sales Inc. food recall: Martina brand Fresh Whole Mangoes Official notice ↗
Product may be contaminated with Salmonella
-
AVID Medical, Inc. medical device recall: Haylard 18G SINGLE SHOT EPI TRAY
Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
-
Quality Dairy Farms Inc. food recall: Mercer's brand 6 ICE CREAM SANDWICHES TO GO Official notice ↗
Undeclared peanuts
-
Buckhead Meat Company D.B.A. Trinity Seafood food recall: Buckhead Official notice ↗
The Firm was notified by NJ Department of Health of two samples collected from tuna with reported high levels of scombrotoxin.
-
Everything Sprouts, LLC food recall: Everything Sprouts and Calco branded Alfalfa Sprouts
Sprouts may be contaminated with STEC E. coli and/or Salmonella.
-
Ptw Freiburg medical device recall: Brand Name: VERIQA Official notice ↗
When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly, which may lead…
-
Vitruvias Therapeutics Inc drug recall: Thyroid Tablets
Superpotent Drug
-
Straumann USA LLC medical device recall: GM Helix Implant Official notice ↗
There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
-
Bayer Medical Care, Inc. medical device recall: MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT… Official notice ↗
Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
-
Well Lead Medical Co. Ltd medical device recall: SunMed Tracheal Tube Official notice ↗
The 6Fr suction catheter could not pass through the samples smoothly.
-
Mirion Technologies (Capintec), Inc. medical device recall: Captus 4000e Thyroid Uptake System Official notice ↗
Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its lowest position, which is approximately 25 inches (63.5 cm) from…
-
AVID Medical, Inc. medical device recall: Halyard IV START KIT NON-STERILE REF: KRIV26-02
Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides
-
Abiomed, Inc. medical device recall: Automated Impella Controller
The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
-
Medline Industries, LP medical device recall: Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of…
-
Maquet Cardiopulmonary Gmbh medical device recall: Percutaneous Insertion Kit Official notice ↗
The packaging may not consistently maintain sterile barrier integrity.
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Medline Industries, LP medical device recall: Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A Official notice ↗
Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of…
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Pi Cardia Ltd medical device recall: Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US Official notice ↗
Transfemoral catheter, positing arm may detached due to weld issue.
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GE Healthcare medical device recall: Centricity Enterprise Archive V2 Official notice ↗
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or…
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Safecor Health, LLC drug recall: Fluphenazine HCl Elixir Official notice ↗
Failed Stability Specifications
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Datex-Ohmeda, Inc. medical device recall: Aisys Official notice ↗
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system…
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ICU Medical, Inc. medical device recall: CADD Yellow Medication Cassette Reservoir with NRFit connector US… Official notice ↗
Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of…
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GE Medical Systems Information Technologies Inc medical device recall: Carescape Central Station CSCS V3 MAS800 Desktop Part Number… Official notice ↗
Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant…
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Stryker Sustainability Solutions medical device recall: REF:2B5LT Ethicon Endo-Surgery Official notice ↗
Reusable access port system may crack or seperate during use.
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Boston Scientific Corporation medical device recall: Boston Scientific Corporation StoneSmart Connect Console Contents Official notice ↗
A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may…
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Medical Action Industries, Inc. 306 medical device recall: Blood Culture Collection Venipuncture Kit 20/Cs Official notice ↗
Blood culture convenience kits contain a component subject to a drug recall that due to an an open or incomplete seal on the packaging of the applicator may compromise…
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Noxbox Ltd medical device recall: NOxBOXi Nitric Oxide Delivery System Official notice ↗
Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.
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Taylor Fresh Foods Inc food recall: Diced Jalapenos. Ingredients: Jalapeno Pepper
Potential contamination with Salmonella.
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Happiest Baby, Inc medical device recall: Happiest Baby Official notice ↗
Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
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NatureBest Pre-Cut & Produce LLc food recall: PICO DE GALLO-MILD-4oz PICO DE GALLO-MILD-6/14oz PICO DE GALLO-4/5#…
Jalapenos have the potential to be contaminated with Salmonella
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embecta Medical II LLC medical device recall: Ewo_02512 Official notice ↗
Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
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Medline Industries, LP medical device recall: Medline Convenience Kit: OPEN HEART A PACK Official notice ↗
The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured.…
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Elegant Foods, LLC food recall: Elegant Foods Coconut Flakes Official notice ↗
Undeclared sulfites
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Philips North America medical device recall: Philips Patient Information Center iX REF:866389 Official notice ↗
Due to software malfunction, patient information system may freeze and become unresponsive.
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Howmedica Osteonics Corp. medical device recall: AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500… Official notice ↗
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for…
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Nova Biomedical Corporation medical device recall: StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose…
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously…
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Bard Access Systems, Inc. medical device recall: Power-Trialysis Short-Term Straight Dialysis Catheter
this is a downstream recall of class I recall RES 98777
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F & A Foundation medical device recall: Reign Medical Clench Staple System Official notice ↗
Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.
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restor3d Inc. medical device recall: Kinos Axiom Total Ankle System with Axiom PSR Official notice ↗
Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation,…
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Wilson-Cook Medical Inc. medical device recall: Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY… Official notice ↗
Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU).
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Nuclein LLC medical device recall: Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR… Official notice ↗
Due to a software issue
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Bd Switzerland Sarl medical device recall: BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563…
Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.
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ICU Medical, Inc. medical device recall: Plum administration sets Official notice ↗
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC)…
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Toyworld168 Recalls Rainbow Mystery Squishy Bun Toys Due to Risk of Serious Injury or Death from Water Bead Ingestion; Violate Mandatory Standard for Toys
The squishy bun toys violate the mandatory safety standard for toys because the water beads inside the dumplings expand larger than permitted, posing a deadly ingestion…
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Tongyang Cycling Recalls Basecamp Bicycle Helmets Due to Risk of Serious Injury or Death from Head Injury; Violate Mandatory Standard for Bicycle Helmets
The recalled helmets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the impact attenuation, positional stability and…
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Sauna360 Recalls Infrared Saunas, Hybrid Infrared Saunas and Infrared Kits Due to Risk of Serious Injury or Death from Fire and Burn Hazards
The infrared panels in the saunas and kits can short circuit, causing them to overheat, posing a risk of serious injury from fire and burn hazards.
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Sauna360 Expands Recall of Tylö Halmstad and Kiruna Hybrid Saunas Due to Fall Hazard; New Remedy Provided
The saunas contain a bench that can collapse, posing a fall hazard to consumers. The previous recall repair was ineffective; a new repair is now being offered.
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SHEIN Distribution Corporation Recalls Pull and Chew Montessori Teething Toys Due to Risk of Serious Injury or Death from Choking Hazard; Violate Mandatory Standard for Toys
The recalled teething toys violate the mandatory safety standard for toys because the silicone strings are smaller and longer than permitted. The silicone strings can…
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Regfear Recalls BedsPick Mattresses Due to Risk of Serious Injury or Death from Fire; Violate Mandatory Flammability Standard for Mattresses
The mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.
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Melissa & Doug Recalls Fire Truck Activity Board Toys Due to Risk of Serious Injury from Choking Hazard; Sold Exclusively at Target
The fire hose port can come loose and detach, posing a risk of serious injury from choking hazard.
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LANCHEZ Pressure Washers Recalled Due to Serious Risk of Injury or Death from Shock and Electrocution Hazards
The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and an adequate-length power cord, which may encourage use of an extension cord,…
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JKMAX Recalls Heated Blankets and Heating Pads Due to Fire and Burn Hazards
The internal wire heating elements of the blankets and pads can overheat, posing fire and burn hazards to consumers.
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Hayward Industries Recalls Universal Pool Heaters Due to Risk of Serious Injury or Death from Carbon Monoxide Poisoning Hazard.
During operation, the heaters can produce high levels of carbon monoxide (CO), posing a risk of serious injury or death from carbon monoxide poisoning.
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Friedrich Air Conditioning Recalls KÜHL Window Air Conditioners Due to Risk of Serious Injury or Death from Fire and Burn Hazards
The control board inside the motor of the recalled air conditioners can fail, posing a risk of serious injury or death from fire and burn hazards.
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Esjay US Recalls Toddler Busy Board Montessori Toys Due to Risk of Serious Injury or Death from Choking; Violates Small Parts Ban
The recalled toy violates the small parts ban because the product is for children under three years of age and the red knobs can detach, posing a deadly choking hazard.
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Colerinsec Recalls Jerify Magnetic Stick Figure Toy Sets Due to Risk of Serious Injury or Death from Magnet Ingestion; Violate Mandatory Standard for Toys
The magnetic humanoid toy Sets violate the mandatory standard for toys because they can liberate loose high-powered magnets posing an ingestion hazard to children. When…
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Char-Broil Recalls Bistro Pro Electric Grills Due to Risk of Electric Shock
The grounding wire for the grill's heating element can disconnect and lose fault protection, posing an electric shock hazard.
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OurPharma LLC drug recall: fentaNYL Citrate Official notice ↗
Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry…
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International Sprout Holdings, Inc food recall: Alfalfa
Potential E. coli and Salmonella contamination
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ImprimisRx NJ LLC drug recall: Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution Official notice ↗
Subpotent Drug
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Ajanta Pharma USA Inc drug recall: Fluphenazine Hydrochloride Tablets Official notice ↗
Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent.…
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B Braun Medical Inc drug recall: 0.9% Sodium Chloride Injection
Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
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Euro Foods Group USA Nj Inc food recall: Crown Farms Dried Suri Cut
The firm imported and distributed dried ribbon fish that was not properly eviscerated prior to drying.
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Ferrero USA food recall: Fannie May & XO Marshmallow Pixie S'mores Collection Official notice ↗
Undeclared milk and pecans
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Atrium Medical Corporation medical device recall: Getinge PVC Thoracic Catheter Official notice ↗
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
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Baxter Healthcare Corporation drug recall: Dextrose Injection
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
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L-Nutra Inc food recall: Prolon Everyday Apulian Almond & Cocoa Spread Official notice ↗
Undeclared allergen (tree nuts): hazelnut, cashew, and pistachio.
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American Regent, Inc. drug recall: Epinephrine Injection
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and…
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Windstone Medical Packaging, Inc. medical device recall: AMS Convenience Kit: DSAEK Pack - RX Official notice ↗
The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts (BOPs) that have detached…
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Exotique Foods Canada food recall: Momchipz Gluten Free Veggie Chips Broccoli Florets & Cauliflower
Undeclared Wheat.
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Given Imaging Ltd. medical device recall: Bravo CF capsule delivery device
Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruction of the…
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Medical Action Industries, Inc. 306 medical device recall: Kit: Epidural/Pain TQC 20/Cs
Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
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Lutronic Corporation medical device recall: Product Name: DermaV Laser System Model/Catalog Number: DermaV… Official notice ↗
Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.
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Nipro Renal Soultions USA, Corporation medical device recall: MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201 Official notice ↗
Hemodialysis concentrates contain high endotoxin levels
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HeartSine Technologies Ltd medical device recall: HeartSine SAM 350P 350P US Device Official notice ↗
Due to a damaged (over stretched) membrane tail that causes an intermittent fault.
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AVID Medical, Inc. medical device recall: Halyard IV Start Kit Non-Sterile REF: KRIV26-02 Official notice ↗
Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles in the paper lidding which may…
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C.R. Bard Inc medical device recall: Products that contain the Pericare Wipes: Bardex Lubricath Foley… Official notice ↗
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
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ZMC Group Expands Recall of Light-Up Children’s Toys Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Toys
The recalled light-up toys violate the mandatory safety standard for children’s toys because the toys contain button cell batteries that can be easily accessed by…
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FJTJBSI Recalls Six-Drawer Dressers Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violate Mandatory Standard for Clothing Storage Units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to…
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Triumph Motorcycles Recalls Closed Course Competition Motorcycles Due to Risk of Serious Injury or Death from Crash Hazard
The engine rocker arm on the recalled motorcycles can seize or stick and the exhaust valves can remain open or break, posing a risk of serious injury or death from a…
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Cade California Electronic Recalls Finger Light Toys Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Toys
The recalled finger lights violate the mandatory safety standard for toys because the toys contain button cell batteries that can be easily accessed by children. If…
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Dual Fuel Ranges Recalled Due to Risk of Serious Injury or Death from Fire or Explosion Hazards; Manufactured by AGA Rangemaster
Dual Fuel Ranges with a missing cap from the gas test port can cause a gas leak, posing a risk of serious injury or death from fire or explosion hazards.
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Prepared Hero Recalls Fire Spray Canisters Due to Risk of Serious Injury or Death from Fire and Burn Hazards
The recalled fire spray canister can deteriorate overtime, causing it to rupture and fail to operate during a fire, posing the risk of serious injury or death from fire…
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Guang Zhou Recalls Wantefully Hair Dryer Brushes Due to Risk of Serious Injury or Death from Electrocution, Shock and Burn Hazards; Violate Federal Regulations
The recalled hair dryer brushes are in violation of federal regulations for hair dryers as they lack an integrated immersion protection device, which presents a…
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SQT Recalls Lontcs Busy Boards Due to Risk of Serious Injury from Lead Poisoning; Violate Federal Lead Paint Ban
The toys’ zipper contains levels of lead that exceed the standard set in the federal lead paint ban. Lead is toxic if ingested by young children and can cause adverse…
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Sweet Cubby Recalls Children's Loungewear Sets Due to Risk of Serious Injury or Death from Burn Hazard; Violate Mandatory Standard for Children's Sleepwear
The recalled children’s loungewear sets violate the mandatory flammability standard for children’s sleepwear, posing a risk of serious burn injuries or death.
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Junkins Recalls DHASUWT Hair Dryer Brushes Due to Risk of Serious Injury or Death from Electrocution, and Shock Hazards; Violate Federal Regulations; Smoking and Fire Hazards
The recalled hair dryer brushes lack an integrated immersion protection device, which presents a substantial product hazard to consumers, posing the risk of death or…
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Victgoal Recalls Bicycle Helmets Due to Risk of Serious Injury or Death from Head Injury; Violate Mandatory Standard for Bicycle Helmets
The recalled helmets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the retention system, positional stability and…
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Ricky Joy Recalls More Than 2.3 Million Sour Crush Candy Bottles Due to Risk of Serious Injury or Death from Choking Hazard
The rolling ball on the recalled candy bottles can detach, posing a risk of serious injury or death from choking hazard.
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Philips North America Llc medical device recall: Philips Brilliance. Models: Brilliance iCT Official notice ↗
Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the…
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Supernus Pharmaceuticals, Inc. drug recall: Trokendi XR Official notice ↗
Failed dissolution specifications.
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Lexia LLC drug recall: Broadway Joe's Pain Cream Official notice ↗
CGMP Deviations: Potential contamination of raw material
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Mylan Pharmaceuticals Inc drug recall: Carton label: Mycophenolate Mofetil for injection Official notice ↗
Failed Dissolution Specifications
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Teva Pharmaceuticals USA, Inc drug recall: traZODone Hydrochloride Tablets Official notice ↗
Presence of Foreign Tablets/Capsules
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Golden State Medical Supply Inc. drug recall: Prasugrel HCI Official notice ↗
Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution
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Chiesi USA, Inc. drug recall: Revcovi Official notice ↗
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
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Baxter Healthcare Corporation drug recall: 0.9% Sodium Chloride Injection USP 500 mL
Presence of particulate matter: Particulates identified as fiberglass
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American Health Packaging drug recall: Buprenorphine Sublingual Tablets Official notice ↗
Labeling: Label Mix-up
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Optimal Balance Pharmacy drug recall: Glutathione 200 mg/mL
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
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Sage Products, LLC drug recall: 2% Chlorhexidine Gluconate* Cloth Official notice ↗
Cross Contamination with Other Products
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The Hampton Grocer food recall: THE HAMPTON GROCER brand
Product may be contaminated with Salmonella.
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Mylan Pharmaceuticals Inc drug recall: Prasugrel Tablets Official notice ↗
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
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Allies Group Inc. drug recall: The One Spf 50 Invisible Sunscreen Gel Official notice ↗
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
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Prince Bakery Inc food recall: Prince ITALIAN BREAD Official notice ↗
Sesame is not declared in the ingredient statement but is declared in the statement of identity.
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Savor Seasonings LLC food recall: Organic Cheddar Type Seasoning
Product tested positive for undeclared milk allergen.
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Weis Markets, Inc. food recall: Weis Official notice ↗
Product has high patulin levels
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Marina Del Rey Foods inc. food recall: Frankie's Organic Plant-Based Puffs Vegan Cheddar
Product tested positive for undeclared milk.
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Ron's Home Style Foods, Inc. food recall: Item # DIPPIC0205RFS Pico de Gallo 5 lb packaged in round plastic…
Products were manufactured with jalapenos that have the potential to be contaminated with Salmonella
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Medline Industries, LP medical device recall: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL… Official notice ↗
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal…
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Baxter Healthcare Corporation medical device recall: Baxter Novum IQ Syringe Pump Official notice ↗
A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI)…
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Fresenius Medical Care Renal Therapies Group, LLC medical device recall: 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number… Official notice ↗
Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss…
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Cardinal Health 200, LLC medical device recall: Presource Packs Containing CliniClean Pericare Wipes within BD… Official notice ↗
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a…
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Bionpharma Inc. drug recall: Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10… Official notice ↗
Presence of Foreign Tablets/Capsules
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B Braun Medical Inc medical device recall: Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK… Official notice ↗
Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.
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Ukrop's Homestyle Foods LLC food recall: Bread Pudding with Vanilla Sauce NET WT 13.8 OZ Official notice ↗
Foreign object: metal fragments
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Fresenius Medical Care Renal Therapies Group, LLC medical device recall: GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B Official notice ↗
Complaints of blue-green discoloration in product
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Diagnostica Stago, Inc. medical device recall: STA Staclot Protein S Official notice ↗
A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
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Boston Scientific Corporation medical device recall: LUX-Dx Official notice ↗
There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification…
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Wonton Specialists food recall: Wonton Specialist Inc. Pan Fried Noodle Official notice ↗
Undeclared FD&C Red No. 40
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Baxter Healthcare Corporation drug recall: Vancomycin Injection Official notice ↗
CGMP Deviations
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Johnson & Johnson Surgical Vision, Inc. medical device recall: HEALON EndoCoat PRO Official notice ↗
Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during…
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AVID Medical, Inc. medical device recall: Halyard medical convenience kits labeled as: 1) ENT Official notice ↗
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models…
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Medos International Sarl medical device recall: Velys Enabling Tech Robotic-Assist Station REF: 451611001 Official notice ↗
Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
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Fayus Inc. food recall: OLA-OLA Pounded Yam
Undeclared milk.
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Medline Industries, LP medical device recall: Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT Official notice ↗
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper…