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FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Medical device recalls are the FDA's highest-volume stream. They cover implantable devices like pacemakers and joint replacements, hospital diagnostics and lab analyzers, surgical instruments, software-as-a-medical-device, and consumer-facing hardware like CPAP machines, blood-pressure cuffs, and glucose monitors. The volume comes from the wide range of products in scope and from the FDA's broad definition of 'corrective action' — software updates, IFU revisions, and labeling corrections all show up as recalls.
For Class I device recalls, the device's defect creates a reasonable risk of serious injury or death — these are the urgent ones. Class II covers issues that may cause temporary or medically reversible harm, often around accuracy or calibration. Class III is for products that don't comply with FDA rules but pose no real safety risk; in practice many software-update letters are Class III.
If you depend on a recalled device for ongoing care, don't disconnect or stop using it before talking to the prescribing clinician — interrupting therapy for a CPAP or a continuous glucose monitor can be more dangerous than the recall it's responding to. Almost every device recall offers a remedy that doesn't require you to surrender the device first.
Medtronic is recalling perfusion system tubing packs due to manufacturing defects involving incomplete or insufficient welds. No injuries have been reported, but the defect may affect product performance and safety.
Specific lots of Medtronic's CB10W65R1 perfusion system tubing packs may have incomplete or insufficient welds that could compromise system integrity during cardiac surgery.
Bard Peripheral Vascular recalls VENOVO Venous Stent System 9F due to reports that the proximal end fails to expand immediately upon deployment and remains connected to the delivery system.
Medtronic is recalling specific lots of CB4W67R20 Custom Perfusion System tubing packs due to incomplete welds that could affect system performance. The recall affects 61 packs distributed across nine states.
Medtronic is recalling specific lots of CB7J98R7 Custom Pack perfusion system tubing because some units may have insufficient or incomplete welds. The defect could affect device performance during cardiac surgery.
Medtronic is recalling CB10R55R5 perfusion system tubing packs due to insufficient or incomplete welds that could compromise device function. The recall affects five tubing packs distributed across nine U.S. states.
Medtronic recalls specific lots of HY8M63R4 Adult ECC Custom Perfusion System tubing packs due to potentially insufficient or incomplete welds, which could affect performance during surgical procedures.
Medtronic Perfusion System tubing packs are recalled due to manufacturing defects involving insufficient or incomplete welds in the CB10W63R1 lot. Affected devices may malfunction during use.
Covidien LP is recalling HME (Heat and Moisture Exchanger) units for tracheostomized patients due to potential deviations from validated ethylene oxide sterilization parameters. The recall affects 10,890 units distributed worldwide and in specific U.S. states.
Radiometer is recalling ABL90 FLEX PLUS Analyzers with E3800 PC units due to an internal clock issue. Approximately 4,135 units are affected worldwide, including 1,277 in the United States.
WorkMate Claris v.1.2 Upgrade Kits may lose functionality or display a black screen during operation due to a software error.
Medtronic has recalled 16 tubing packs from its CB10R79R6 Custom Perfusion System due to insufficient or incomplete welds in specific lots. The defect may compromise device integrity during use.
Medtronic recalls custom perfusion system tubing packs due to potential manufacturing defects in welds. Specific lots may have insufficient or incomplete welds that could affect system integrity.
Medtronic is recalling HY10L28R3 perfusion system tubing packs (lot 221679870) manufactured with insufficient or incomplete welds. The recall affects units distributed in nine U.S. states.
Medtronic is recalling 18 tubing packs used in perfusion systems due to potentially incomplete or insufficient welds that may compromise device integrity. No injuries have been reported.
Corin Ltd is recalling TriIFit TS size 2 hip prosthesis stems that were labeled incorrectly as TriFit CF size 7 stems, and vice versa. Patients receiving mismatched implants face risk of poor fit and potential complications.
Corin TriFit hip prosthesis components from lot 467881 were mislabeled, with size 2 stems labeled as size 7 and vice versa. Surgeons could implant incorrect components during hip replacement surgery.
Radiometer Medical ApS is recalling ABL90 FLEX Analyzers with E3800 PC units due to an internal clock issue. Approximately 3,346 units are affected globally, with only 2 in the United States.
Medivators, Inc. recalls 1,381 cases of dialysate concentrate due to a manufacturing anomaly that may result in out-of-specification formulation. Affected lots may not function properly in hemodialysis treatment.
Radiometer Medical ApS recalls E3800 PC Units spare parts due to an internal clock defect affecting analyzers. Approximately 965 units have been distributed worldwide, with 35 in the United States.
Siemens Healthcare Diagnostics is recalling Atellica CH 930 Analyzers with photometer lamps that may reach saturation without alerting users, potentially producing inaccurate patient test results.
Medtronic recalls 11 packs of HY10Y54R4 Custom Perfusion System tubing manufactured with insufficient or incomplete welds. No injuries have been reported.
Medtronic is recalling specific lots of BB11J14R2 Bridge Custom Perfusion System tubing packs due to incomplete or insufficient welds that may have occurred during manufacturing.
Medtronic is recalling 26 tubing packs from its Custom Perfusion System (Lot 221148857) due to potential manufacturing defects. Specific lots may have been manufactured with insufficient or incomplete welds.
The FDA is recalling VENOVO Venous Stent System units due to reports that the proximal end may fail to expand immediately upon deployment and remain connected to the delivery catheter.
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