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 the agency’s own highest classification or reported deaths or serious injuries, 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
IntraSight Mobile IVUS Systems touch screen modules lack required labeling information including device identifier and manufacturer information. Affected units were distributed to healthcare facilities in the US and internationally.
WHPM Inc. is recalling approximately 535,755 First SIGN SARS-CoV-2 Antigen Tests distributed in California, Florida, Louisiana, Massachusetts, and Texas. The tests were sold without FDA Emergency Use Authorization or clearance.
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.
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.
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.
DeRoyal Industries is recalling 1,360 DEXMED ACCESS CENTER TRAY kits with Prevantics antiseptic swabs due to uncertain validation of manufacturing test methods. The affected kits were distributed in Florida, New Jersey, and Tennessee.
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.
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.
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.
SyncVision cardiac imaging systems may display incorrect measurements during same-session procedures if workflow steps are performed out of order, potentially affecting patient treatment.
Abbott Molecular is recalling the Alinity m HBV AMP Kit due to potential for falsely high results on negative samples. The kits are used for Hepatitis B virus testing in the US and internationally.
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.
GE Healthcare Revolution Apex and Revolution CT systems display accumulated radiation doses inaccurately high in certain situations. No injuries have been reported.
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.
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.
Draeger Medical is recalling Evita V500 ventilators due to cybersecurity vulnerabilities that could potentially compromise device functionality. Affected units require software remediation.
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 Revolution CT scanners display inaccurate radiation dose values in certain situations. This could affect clinical dosing decisions during patient scans.
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.
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.
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.
Draeger Medical is recalling Babylog VN500 ventilators for neonatal and pediatric patients due to cybersecurity vulnerabilities. The devices are not equipped against potential cyber threats.
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.
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.
Stradis Medical is recalling Lum Lam Custom Pack Anesthesia Kits because the outer bag may be perforated or torn, potentially compromising the kit's sterility. Two lot numbers are affected.