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
Maquet Cardiovascular is recalling the Ultima Activator II Reusable Drive Mechanism due to potential corrosion on pins, which could cause allergic reactions, metal toxicity, and other delayed health effects.
Ventana Medical Systems has recalled 9,214 BenchMark ULTRA and DISCOVERY ULTRA instruments due to potential fluid leak that could cause electrical short circuit, smoke, and fire.
Maquet Medical Systems is recalling certain Cardiohelp-i Transport Guard units due to a potential loose cylindrical pin that may jam the locking mechanism. This could prevent the device from opening or cause complete disassembly, potentially delaying critical cardiac support.
Abbott Molecular recalled Alinity m HBV Application Specification Files due to potential for incorrect high quantitation results on negative samples, which could affect test accuracy for hepatitis B virus detection.
Stradis Medical is recalling Surgicare Neuro Pack neurological kits because the outer bag may be perforated or torn, potentially compromising product sterility. 176 units were distributed in Indiana, Texas, and Pennsylvania.
Siemens is recalling seven Symbia Intevo SPECT/CT imaging systems due to a quality defect in the bolts that secure the CT balancing weights, which could create a safety issue.
GE Healthcare's 1.5T and 3.0T SIGNA Excite HD MRI systems may display medical images flipped left to right, potentially affecting diagnostic accuracy. The recall involves 76 units distributed worldwide.
Abbott is recalling 402 kits of ARCHITECT STAT myoglobin calibrator that failed stability testing and may produce out-of-specification calibration results. The affected calibrators could impact the accuracy of myoglobin measurements used in clinical diagnostics.
Shimadzu FLUOROspeed X1 fluoroscopy systems may deliver radiation doses exceeding federal regulatory limits in specific fluoroscopic operating modes due to inadequate installation adjustment criteria.
Stradis Medical is recalling 348 units of its Total Joint Pack Surgical Kit due to risk of outer bag tears or perforations that could compromise kit sterility. The recall affects units distributed in Indiana, Texas, and Pennsylvania.
GE Healthcare is recalling 10 Signa 1.5T TwinSpeed MRI systems worldwide due to a potential defect where magnetic resonance images may be flipped left to right.
Stradis Medical is recalling Anterior Hip Pack surgical kits due to perforated or torn outer bags that may compromise sterility. No illnesses have been reported.
Shimadzu Medical Systems recalls 176 SonialVision G4 X-ray systems that may emit radiation doses exceeding federal standards in some fluoroscopic mode cases. No injuries have been reported.
GE Healthcare is recalling 55 SIGNA Excite 3T MRI systems due to potential for images to be flipped left to right, which could affect diagnostic accuracy. The affected systems were distributed worldwide.
Philips is recalling adult Smart PADS cartridges for HeartStart HS1 defibrillators due to potential gel separation from the pad backing. Affected pads may have reduced gel contact, potentially affecting device performance.
Stradis Medical is recalling 76 units of Total Knee Surgical Kits with potentially perforated or torn outer bags that may compromise sterility. Distribution occurred in Indiana, Texas, and Pennsylvania.
GE Healthcare Revolution CT scanners display inaccurate radiation dose values in certain situations. This could affect clinical dosing decisions during patient scans.
DeRoyal Industries is recalling 400 DeRoyal ST Neonatal Dressing Change Kits due to uncertain validation of manufacturing test methods. The recall affects kits distributed to healthcare facilities in Florida, New Jersey, and Tennessee.
Hologic is recalling 2,061 Panther Fusion GBS Assay Cartridges because samples at or near the limit of detection may produce false negative results, risking missed diagnosis of group B streptococcus infection.
Shimadzu SonialVision safire X-ray systems may emit radiation exceeding federal limits during some fluoroscopic procedures. The manufacturer is addressing installation criteria to prevent potential dose violations.
DeRoyal Industries is recalling 780 Ultra/Mammo Tray kits with antiseptic swabs due to uncertain validation of manufacturing test methods. Kits are used for patient skin preparation before surgery or injection.
GE Healthcare has recalled 653 SIGNA MRI systems worldwide due to a potential defect that could flip medical images left to right. This could affect diagnostic accuracy in patient care.
Philips Healthcare is recalling the StentBoost Live R2.0 application due to a software configuration error. The imaging system fails to stop image acquisition automatically, continuing indefinitely while the pedal is pressed instead of stopping after 40 images.
Philips is recalling 331,712 infant and child defibrillator pads worldwide due to potential gel separation from the pad backing. The gel may fold onto itself or separate nearly completely, leaving reduced surface coverage on the pad.
DRG International recalls its C-Peptide ELISA kit (Catalog # EIA-1293) after the standards were found to have optical density below the required threshold. The defect may cause invalid test runs and delayed patient results.