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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.
Lamaze Chill Teether teething rings are being recalled due to potential microbial growth in the internal fluid. This poses an infection risk, particularly for children with weakened immune systems.
GE Medical Systems' Centricity Universal Viewer 6.0 image display software may hide medical studies from users after IAS tool installation, requiring GE assistance to access hidden images and causing delays in reading diagnostic studies.
HeartWare Model 1102 cardiac assist devices are being recalled because the driveline cover may harden over time, preventing timely access to the critical driveline connector during urgent clinical situations.
The driveline cover on some HeartWare Model 1101 implanted pumps may harden over time, making it difficult to access the driveline connector. This could delay urgent maintenance, potentially causing patient harm.
GE Vivid S6 ultrasound systems are recalled for a potential battery hazard. If not replaced at the recommended 2-year interval, batteries may fail, emit smoke, or catch fire.
Fresenius Medical Care is recalling 2008T and 2008T Bluestar Hemodialysis Machines with CDX due to a software and hardware sensitivity to electromagnetic interference that triggers false alarms.
HeartWare Model 1100 driveline covers may harden over time, making it difficult or impossible to access the driveline-to-controller connector. A delay in accessing the connector during an urgent issue could result in prolonged pump stoppage and patient harm.
GE Medical Systems is recalling Vivid q N ultrasound systems due to potential battery failures that could emit smoke or catch fire if batteries are not replaced per the 2-year service manual recommendation.
GE Healthcare is recalling B125M patient monitors because the CO2 measurement display can be inaccurate at locations above sea level when configured for mmHg or kPa units.
The driveline cover on HeartWare HVAD Pump Kits may harden over time, preventing access to the driveline to controller connector. This could delay urgent intervention for critical device issues.
GE Medical Systems is recalling B105M patient monitors that display inaccurate CO2 readings when used at elevations above sea level. The issue affects monitors showing CO2 in mmHg or kPa units.
A hardened driveline cover on the HeartWare HVAD Pump Kit may prevent or delay access to the driveline to controller connector. If urgent servicing is needed, the delay could result in patient harm from pump malfunction.
GE Medical Systems recalled 1,400 Vivid S5 N ultrasound systems for batteries that may fail, emit smoke, or catch fire if not replaced every 2 years as recommended.
Natus Medical is recalling 249 Cranial Access Kits distributed nationwide. The sterile surgical drape liners are difficult to remove without damage, potentially rendering the kits unusable for neurosurgical procedures.
DeVilbiss is recalling the 525 oxygen concentrator because the device can become excessively hot, with external parts potentially exceeding 105.8 degrees Fahrenheit. The firm has updated the user manual to include additional safety warnings.
GE B125M patient monitors may display inaccurate CO2 measurements at high elevations when using mmHg or kPa units. Measurement accuracy can be affected in locations significantly above sea level.
Baxter is recalling approximately 14 million units of Revaclear 300 dialyzers worldwide due to polyurethane displacement that could cause blood leaks. No injuries have been reported.
Medical Action Industries' Port a Cath Kit (cardiac catheter introduction kit) has been subject to an FDA Class II recall affecting 198 cases distributed in Virginia. The specific reason for recall was not provided by the FDA.
GE Vivid S6 N ultrasound systems may experience battery failure, smoke, or fire if batteries are not replaced every 2 years as recommended. Clinicians should replace batteries per manufacturer Service Manual instructions.
Corin Ltd is recalling BIOLOX DELTA ceramic hip replacement heads because some units are labeled with incorrect sizes. The recall affects 12 units distributed in seven U.S. states.
Baxter Healthcare Corporation is recalling 3.6 million Revaclear 400 Dialyzers due to a manufacturing defect where a twisted gasket could cause internal blood leaks during hemodialysis treatment.
HeartWare HVAD Pump Kit driveline covers may harden over time, making it difficult or impossible to access the driveline connector for urgent servicing. Delayed access could result in patient harm from prolonged pump stoppage.
Medical Action Industries is recalling Littauer surgical scissors because the sterile instruments may contain debris that could compromise their safety during clinical use.
GE Healthcare is recalling certain B105P patient monitors because they may display inaccurate CO2 measurements when used in locations not at or near sea level with mmHg or kPa units selected.
Howmedica Osteonics Corp. is recalling Full Dose CE Simplex P Single Bone Cement because the included instructions for use lack Turkish language translations. The product content itself is accurate; only the language translation is missing.
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