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
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.
Aesculap Implant Systems LLC recalls ENNOVATE SET SCREW spine implants because packages may contain incorrect screws. Six units distributed in Georgia and Texas.
Pentacam eye imaging devices with certain software versions have a bug that causes inaccurate surgical planning printouts for toric intraocular lens procedures.
Boston Scientific is recalling ZOOM LATITUDE programmers due to potential software anomalies that could affect communication with implantable defibrillators. No injuries have been reported.
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.
Qiagen's FGFR RGQ RT-PCR Kit may produce false positive results, leading to incorrect lab reports. This could expose cancer patients to inappropriate or suboptimal treatment.
Aggredyne, Inc. is recalling the AggreGuide A-100 Instrument due to a software design defect that causes the device to run assays at 0 RPM, resulting in no blood mixing and inaccurate test results displayed as Low.
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.
Siemens has recalled Artis icono X-ray imaging systems due to a potential hardware issue affecting a specific lot of X-ray tubes. If the error detection mechanism fails, the system cannot release X-rays until it is shut down.
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.
New Standard Device Inc is recalling Metalogix Self-Drill Half-Pins used in external fixation surgery due to reports of tip breakages occurring during surgical procedures.
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.
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.
Abbott is recalling one lot of ARCHITECT STAT Troponin-I Reagent Kits due to insufficient heterophilic blocking agents in the conjugate, which 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.
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.
Boston Scientific recalled the ZOOM LATITUDE Programmer (Model 2868) for potential software anomalies affecting communication with certain transvenous defibrillators. No injuries have been reported. The recall involves 17,172 units distributed worldwide.
Siemens has recalled Artis Q and Artis Q.zen X-ray imaging systems due to a potential X-ray tube hardware defect. In rare cases, if error detection fails, the system will not be able to release X-ray until shut down; 1,389 units are affected globally.
The FDA is recalling INTERA 3000 implantable hepatic infusion pumps due to a malfunction causing higher-than-expected medication flow rates. Patients should contact their healthcare provider.
Getinge Servo ventilators may fail to deliver ventilation and stop functioning, potentially causing oxygen deprivation and serious harm to critical care patients.
Synapse Biomedical is recalling the NeuRx Diaphragm Pacing System External Pulse Generator due to a circuit board defect causing performance degradation, potentially leading to cardiac complications, breathing failure, or device shutdown.
Hamilton's HAMILTON-C6 intensive care ventilator status indicator board may become loose, allowing water or disinfectants to enter the device and cause technical faults that could force the ventilator into unsafe modes where patients breathe unassisted room air.
McKesson is recalling Wetfield Eraser Bipolar Hemostatic devices that were exposed to elevated facility temperatures from June to August 2021 prior to delivery. This exposure may have impacted the devices' effectiveness.
Multiple Alcon contact lens solutions were recalled due to facility temperature excursions during storage and transit that may have reduced product effectiveness. Affected products include Clear Care and Opti Free Replenish solutions distributed nationwide between June and September 2021.
McKesson recalls gynecological catheters that may have been exposed to temperatures higher than intended during storage, potentially affecting product effectiveness. Affected units were received between June and September 2021.