Medical device recalls
Recalls
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Edwards Lifesciences, LLC medical device recall: Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial…
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
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Baxter Healthcare Corporation medical device recall: Hillrom Q-Link 13 component
The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical…
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Maquet Critical Care AB medical device recall: Servo-u Ventilator System. Model Number: 6688600
Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an…
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Philips Respironics, Inc. medical device recall: BiPAP V30 Auto Ventilator. Intended to provide non-invasive…
This device does not indicate for use in patients with respiratory failure.
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Integra LifeSciences Corp. (NeuroSciences) medical device recall: MicroMyst Applicator
Lack of sterility assurance.
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Integra LifeSciences Corp. (NeuroSciences) medical device recall: Extended Tip Applicator
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
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SunMed Holdings, LLC medical device recall: Broselow Pediatric Emergency Rainbow Tape
The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect…
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Cook Incorporated medical device recall: Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate…
Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.
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Dexcom, Inc. medical device recall: Dexcom G6 Glucose Receiver
Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood…
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Fresenius Kabi USA, LLC medical device recall: IVENIX INFUSION SYSTEM LVP Blood Products Administration Set
Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood…
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Zyno Medical LLC medical device recall: Z-800 Infusion System. Intended to provide intravenous infusion of…
Unreleased software versions were installed on distributed devices without verification or validation.
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Covidien medical device recall: Newport HT70 Ventilator
Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus…
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MEDLINE INDUSTRIES, LP - Northfield medical device recall: Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI…
Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break…
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SunMed Holdings, LLC medical device recall: Adult Manual Resuscitator with Medium Adult Mask
Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient…
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Ethicon Endo-Surgery Inc medical device recall: Endopath Echelon Vascular White Reload for Advanced Placement Tip
Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will…
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Baxter Healthcare Corporation medical device recall: Baxter Novum IQ LVP INFUSION SYSTEM
There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set…
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Centerline Biomedical Inc medical device recall: Centerline Biomedical IOPS Guidewire 2
Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
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C.R. Bard Inc medical device recall: Bard Minnesota Four Lumen Esophagogastric Tamponade Tube
Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or…
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Medical Depot Inc. medical device recall: iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen…
Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.
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Vyaire Medical medical device recall: Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit…
Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including…
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Nipro Renal Soultions USA, Corporation medical device recall: MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201
Potential for the presence of visible foreign matter.
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Baxter Healthcare Corporation medical device recall: Welch Allyn Life2000 Ventilation system
A cybersecurity vulnerability was discovered through internal testing.
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Integra LifeSciences Corp. (NeuroSciences) medical device recall: CODMAN Disposable Perforator
Inadequate weld that can potentially cause the product to disassemble.
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Smiths Medical ASD, Inc. medical device recall: CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply…
Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to…
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Smiths Medical ASD, Inc. medical device recall: CADD-Solis Infusion Pump Models: 1) PUMP KIT
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
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Smiths Medical ASD, Inc. medical device recall: CADD-Solis HPCA Ambulatory Infusion Pump
Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of…
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Bausch & Lomb Surgical, Inc. medical device recall: Intraocular lens. enVista Monofocal IOL
In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and…
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GE Medical Systems China Co., Ltd. medical device recall: GE Healthcare CARESTATION 620 A1
Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these…
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Conavi Medical Inc. medical device recall: Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid…
Due to manufacturing issues there is a potential for the catheter sheath to detach.
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Avanos Medical, Inc. medical device recall: Brand Name: Ballard Product Name: Closed Suction Catheters…
Lack of sterility assurance for closed suction catheter systems
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ZOLL Circulation, Inc. medical device recall: Brand Name: AutoPulse NXT Resuscitation System Product Name:…
AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.
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Thoratec LLC medical device recall: HeartMate Mobile Power Unit: REF: 107754
Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or turning off/restarting,…
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Bard Access Systems, Inc. medical device recall: BD 4 Fr Single-Lumen PowerPICC Catheters
Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to…
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Tandem Diabetes Care, Inc. medical device recall: t:slim X2 Insulin Pump with Interoperable Technology
A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to…
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Qapel Medical Inc. medical device recall: Hippo 072 Aspiration System including Cheetah Delivery Tool and…
Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur.
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MEDLINE INDUSTRIES, LP - Northfield medical device recall: Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION…
Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical.
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MEDLINE INDUSTRIES, LP - Northfield medical device recall: Medline medical procedure kits
Medline medical procedure kits, containing Medtronic Aortic Root Cannula
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Draeger, Inc. medical device recall: Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog…
The potential for cracks forming in the breathing circuit hose.
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Covidien medical device recall: Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable…
Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure,…
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Calyxo, Inc. medical device recall: CVAC Aspiration System
Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions, for patients with…
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Smiths Medical ASD, Inc. medical device recall: smiths medical ProPort Plastic Venous Access System
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
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CareFusion 303, Inc. medical device recall: BD Alaris Systems Manager
Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
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Smiths Medical ASD, Inc. medical device recall: Portex Endotracheal Tube
Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or…
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Medtronic Perfusion Systems medical device recall: Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR…
Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential…
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Baxter Healthcare Corporation medical device recall: Baxter Sigma Spectrum Infusion System
There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
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Bard Peripheral Vascular Inc medical device recall: Rotarex Atherectomy System and Instructions for Use
Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder…
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Biosense Webster, Inc. medical device recall: VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field…
Due to an observed trend of neurovascular events
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Micro Therapeutics, Inc. medical device recall: Medtronic Pipeline Vantage Embolization Device with Shield Technology
Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid…
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Ventec Life Systems, Inc. medical device recall: VOCSN Multi-Function Ventilators: VOCSN+Pro
Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in…
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Philips Medical Systems Nederland B.v. medical device recall: Allura Xper FD10 - Catalog numbers
Possibility of the patient falling from the table related to the mattress used on the patient table.