Recalls
Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.
Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.
The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.
Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.
Minimum severity
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.
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.
NuVasive's X-CORE 2 spinal implants may not disengage properly from the vertebral replacement device, potentially requiring revision surgery. About 2,031 devices worldwide are affected.
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.
HeartWare HVAD ventricular assist pump kits may develop hardened driveline covers that impair access to critical connectors. If urgent servicing is needed, delayed access could result in patient harm from prolonged pump stoppage.
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.
Baxter Healthcare is recalling Revaclear 400 dialyzers due to reports of polyurethane displacement, which could result in blood leaks during dialysis treatment. The recall affects over 6 million units distributed worldwide.
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.
GE Medical Systems is recalling Vivid i ultrasound systems because batteries not replaced every two years may fail, emit smoke, or catch fire. About 7,931 units were distributed worldwide.
Baxter Healthcare recalls Revaclear 400 Dialyzer units due to potential internal blood leaks caused by twisted gaskets. The defect may affect dialysis patients worldwide.
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.
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.
Corin Ltd is recalling BIOLOX Delta Ceramic Hip Implant Heads nationwide due to size labeling errors. The 36XL size is labeled as 32XL and vice versa, which could result in implantation of an incorrectly sized component.
Driveline cover hardening in HeartWare HVAD Pump Kits may prevent access to critical connectors, potentially delaying emergency repairs. Affected patients should contact their Medtronic field representative for assessment.
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' 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.
Baxter Healthcare is recalling Revaclear 400 dialyzers because polyurethane displacement may cause blood leaks during dialysis treatment. Approximately 1.14 million units are affected worldwide.
Medical Action Industries is recalling Littauer surgical scissors because the sterile instruments may contain debris that could compromise their safety during clinical use.
Icotec Ag is recalling six VADER Pedicle System Torque Wrench devices due to a calibration error where the torque limiting function was found to be out of specification, delivering 4 Nm instead of the specified 12 Nm.
ConvaTec is voluntarily recalling AQUACEL Foam Ag Adhesive wound dressings due to visual contamination (brown spots) found on several dressings. Approximately 5,300 units distributed nationwide are affected.
GE is recalling Vivid q ultrasound systems because batteries not replaced every 2 years as recommended may fail and emit smoke or catch fire.
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.
Young Dental Manufacturing has recalled Denticator PICK-A-DENT intradental picks due to mislabeling. The recall affects 600 packs distributed in Iowa, New York, Pennsylvania, Tennessee, Texas, and Canada.
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.