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
GE is recalling B125P patient monitors because CO2 measurements may be inaccurate when used at non-sea-level altitudes in mmHg or kPa mode.
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.
After installing the IAS tool, Centricity PACS-IW Universal Viewer version 5.0 may hide some medical imaging studies without notification. Accessing hidden studies requires GE Healthcare assistance and may cause diagnostic delays.
GE Medical Systems is recalling Vivid S5 ultrasound systems because batteries may fail if not replaced at the recommended 2-year intervals, potentially causing smoke or fire.
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.
The InPen Diabetes Management App may crash on certain Android versions, preventing dose reminders and potentially delaying insulin therapy. This could affect users of the diabetes management system.
HeartWare HVAD Pump Kit driveline covers may harden over time, making them difficult to remove for urgent servicing. In an emergency scenario requiring driveline access, delays could harm patients.
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.
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.
Abbott Molecular is recalling approximately 12,116 units of the Abbott Alinity m Resp-4-Plex Amp Kit due to reports of false positive results and reactive negative controls. No illnesses or injuries have been reported.
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.
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.
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.
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.
Abbott Molecular is recalling specific lots of the Alinity m Resp-4-Plex Amp Kit due to reports of false positive and false negative test results.
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.
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.
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.
Baxter Healthcare recalls Revaclear 400 Dialyzer units due to potential internal blood leaks caused by twisted gaskets. The defect may affect dialysis patients worldwide.
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.
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.
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.
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.
Medical Action Industries is recalling Littauer surgical scissors because the sterile instruments may contain debris that could compromise their safety during clinical use.
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.