Medical device recalls
FDA medical devices recall events posted in the Enforcement Report since Jan 1, 2025 that include a Class I product — FDA's most serious category. 221 events, newest first. Class II and III recalls and older records are in search.
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Recalls
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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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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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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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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…
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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.
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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.
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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…
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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,…
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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.
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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
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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.
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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…
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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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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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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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Bard Access Systems, Inc. medical device recall: BD Needle Kit for Powered Driver 15mm x 15Ga
After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases,…
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Boston Scientific Corporation medical device recall: Boston Scientific ENROUTE Transcarotid Neuroprotection System
Potential for arterial sheath tip separation or partial tip separation during use.
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BMC Medical Co., Ltd. medical device recall: BMC/REACTHEALTH Luna G3 APAP REF LG 3600
Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse
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Baxter Healthcare Corporation medical device recall: Baxter Duo-Vent Solution Set and Male Luer Lock Adapter
Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.
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Spectra Medical Devices, Llc medical device recall: Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium…
Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to…
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AVID Medical, Inc. medical device recall: Halyard convenience kits containing recalled Medline Namic…
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of…
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Boston Scientific Neuromodulation Corporation medical device recall: Infinion Cx Lead Kit
Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to…
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Medical Action Industries, Inc. 306 medical device recall: Pack Angiography NCMC 3/Cs BANNER
Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have particulate within the fluid path, which has the potential to be introduced…
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ResMed Ltd. medical device recall: Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system…
Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation…
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Medline Industries, LP medical device recall: MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality…
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Medline Industries, LP medical device recall: Medline Anterior Hip
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection,…
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Oscor Inc. medical device recall: Abiomed REF: 0052-3025
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines…
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Argon Medical Devices, Inc medical device recall: Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode…
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
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Abiomed, Inc. medical device recall: ABIOMED Impella RP Flex with SmartAssist Set
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues…
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Windstone Medical Packaging, Inc. medical device recall: A M S
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine…
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Medline Industries, LP medical device recall: Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item…
Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on…
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Baxter Healthcare Corporation medical device recall: Hillrom VOLARA System P.CIRCUIT KIT
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level…
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Insulet Corporation medical device recall: Omnipod 5 Pods. Includes the below Model/REF Numbers: 1.…
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus…
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Medtronic Heart Valves Division medical device recall: Medtronic Harmony Delivery Catheter System
Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under…
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Hamilton Medical AG medical device recall: Breathing circuit set
Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result…
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Medline Industries, LP medical device recall: Medline Convenience Kits: 1) DYNJ905503F
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP…
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Abiomed, Inc. medical device recall: Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP.…
Potential for thrombus formation during prolonged use of the introducer.
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Datex-Ohmeda Inc medical device recall: Giraffe Stand-alone Infant Resuscitation System
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended…
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Abiomed, Inc. medical device recall: Impella CP Set with SmartAssist. Product Codes: 1000080
Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory…
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Abiomed, Inc. medical device recall: Automated Impella Controller
Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
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Arrow International, LLC medical device recall: Paracentesis Kit
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and…
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Fresenius Kabi USA, LLC medical device recall: Ivenix Infusion System
Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be…
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Fresenius Kabi USA, LLC medical device recall: LVP software of the Ivenix Infusion System
Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the…
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Draeger, Inc. medical device recall: Atlan A350. Model Number: 8211500. anesthesia workstation
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
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Becton Dickinson & Company medical device recall: BD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5 in
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality…
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B Braun Medical Inc medical device recall: Spinal Needle procedure kits: Material Description
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due…
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Kayserbetten Gmbh & Co. Kg medical device recall: Pediatric care bed
If the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key when the patient (child) is unattended, there is an…
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Abiomed, Inc. medical device recall: Automated Impella Controller
Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were…