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
Stradis Healthcare is recalling VYGON DRESSING CHANGE W/MAXISWAB kits due to potential incomplete seals that could compromise product sterility. Affected consumers should stop using recalled kits.
American Contract Systems recalls various ENT surgical packs that may not have been properly sterilized due to multiple sterilization cycles without adequate validation. The packs were distributed to healthcare facilities in 13 states.
BALT USA recalls the Optima Coil System because devices were distributed with material from an alternate supplier before required testing was approved. No illnesses or injuries have been reported.
American Contract Systems is recalling 39 laparoscopy instrument packs that were exposed to multiple sterilization cycles without validation. The sterilization process was not tested for repeated exposures.
ICU Medical recalls ChemoLock and ChemosafeLock port connectors used in chemotherapy delivery systems due to spring defects that may prevent proper connection or cause unintended disconnection, potentially delaying treatment or exposing patients to caustic substances.
American Contract Systems is recalling PICC line and central line packs due to exposure to multiple sterilization cycles without validation. Two units were distributed to healthcare facilities in 13 U.S. states.
American Contract Systems, Inc. is recalling 116 convenience packs distributed to U.S. health systems and distributors in 13 states because they were exposed to multiple sterilization cycles without validation, potentially compromising device sterility assurance.
American Contract Systems recalls 37 units of neurology surgical packs distributed across 13 US states due to exposure to multiple sterilization cycles without proper validation.
American Contract Systems, Inc. is recalling 57 angiography packs and trays that were exposed to multiple sterilization cycles without proper validation for repeated sterilization exposure.
Medtronic Xomed recalls 1.1 million NIM EMG Endotracheal Tubes worldwide due to reports of airway obstruction. FDA classified this as Class I.
Medtronic Xomed is recalling 81,555 NIM Contact EMG endotracheal tubes worldwide due to reports of airway obstruction during use.
Medtronic Xomed is recalling NIM EMG Endotracheal Tubes due to reports of airway obstruction during use. The recall affects 23,820 units distributed worldwide.
Aesculap Implant Systems LLC recalls ENNOVATE SET SCREW spine implants because packages may contain incorrect screws. Six units distributed in Georgia and Texas.
Corin Ltd is recalling a hip implant stem component (Model 588.3800) after some units failed fatigue testing. The affected devices were distributed to New Jersey only.
Oxford Immunotec recalled 81 T-SPOT.TB diagnostic test kits (Lot TEC4000098) due to storage equipment failure that kept products outside the validated 2-8°C temperature range. The excursion may affect test accuracy.
Medtronic is recalling EverFlex peripheral stents worldwide due to risk of partial deployment. Updated instructions provide a manual deployment workaround to mitigate potential harms.
Pending LLM rewrite. Source: FDA_DEVICE Z-1639-2022.
Qiagen Sciences is recalling therascreen FGFR RT-PCR kits due to increased false positive rates. False results could lead patients to receive unnecessary cancer treatment.
Philips DigitalDiagnost C50 1.1 radiography systems contain a firmware defect in the Wallstand VS2 board that may cause incorrect radiation dose and anatomic marker misalignment. Eleven affected systems were distributed nationwide.
A software defect in the Pentacam AXL Wave eye imaging device's IOL calculator may inaccurately reflect alignment axis and incision position for toric lens surgeries. This affects 21 systems distributed across the U.S.
Oxford Immunotec is recalling 47 units of the T-Cell Xtend REF TTK.610 US test kit due to equipment failure that caused improper storage temperatures outside the validated range. Affected devices may have been compromised.
A software error in the Pentacam HR eye imaging device causes inaccurate IOL calculator output for toric intraocular lens surgical planning. Nineteen systems are affected.
Qiagen's therascreen FGFR RGQ RT-PCR Kit is being recalled for increased false positive results in 29 distributed kits. False positives could lead to incorrect lab reports and inappropriate cancer treatment for patients.
Siemens Healthcare Diagnostics is recalling Dimension Vista CA 15-3 Flex reagent cartridges because the diagnostic test can produce inaccurate results, reading 26–33% lower than actual values, potentially delaying appropriate patient treatment decisions.
Canon Medical's Alphenix i imaging systems may deliver radiation dose rates exceeding acceptable limits during biplane fluoroscopic procedures. Sixteen systems nationwide with software versions 8.0, 9.0, or 9.2 and TFP 1200C detector are affected.