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
The Gallant HF Implantable Cardioverter Defibrillator (REF# CDHFA500Q) may experience a Bluetooth malfunction that prevents remote monitoring and reduces battery life. Consult your healthcare provider.
Medtronic Xomed integrated power console software version 2.7.3.0 has a defect that causes the set number of rotations to mismatch the actual rotations in specific modes when used with M5 handpieces. No injuries have been reported.
Siemens is recalling 373 Artis zee biplane X-ray diagnostic systems due to a cooling circuit defect that could prevent adequate tube cooling. When the coolant level drops, the system may overheat and shut down imaging capabilities.
St. Jude Medical's Merlin 2 programmer software can fail to stop a clinical Decrement Test and restore pacing parameters during in-clinic testing, affecting 401 devices worldwide.
Sartorius Corporation is recalling the Virus Counter Platform Model VC3100 (model numbers VIR-92166, VIR-92341) distributed nationwide to 82 units, classified as a Class II FDA medical device recall.
Matrix Medical Network is recalling 3,226 At-Home COVID-19 Test kits distributed across 24 U.S. states because the tests were not authorized by the FDA for home sample collection.
Acumed 4.0mm x 10mm Cannulated Screws may not have sufficient strength to hold bone fragments in place. This could result in improper bone healing, fracture, or soft tissue damage.
Acon Biotech is recalling Flowflex SARS-CoV-2 Antigen Rapid Tests because the non-EUA authorized kits may produce inaccurate results, including false negatives or false positives.
Siemens Medical Solutions is recalling its Artis Q.zen X-ray imaging system due to a coolant circulation defect that may cause insufficient tube cooling and system shutdown.
Qiagen Sciences LLC is recalling the therascreen KRAS RGQ PCR Kit due to potential false positive or false negative results in KRAS G12C mutation detection. These inaccurate results could invalidate clinical test outcomes.
Siemens is recalling 305 Artis zee floor X-ray imaging systems because the cooling circuit may fail to maintain adequate coolant levels, potentially causing the X-ray tube to overheat. The system includes automatic safeguards that shut down X-ray operation if overheating is detected.
Siemens is recalling 35 Artis icono floor diagnostic imaging systems due to five potential software errors affecting equipment movements and detector control. The defects may limit functionality during procedures and could delay clinical treatment until the system is restarted.
Siemens is recalling 269 Artis Q biplane X-ray systems due to potential coolant level drops that may prevent the X-ray tube from cooling adequately, triggering automatic system shutdown.
Abbott has recalled 588 TactiCath ablation catheters that were preprogrammed with a 'First Use Date' disabling device functionality. The catheters were distributed worldwide and throughout the U.S.
The Sight OLO blood analysis device may display and print incorrect reference ranges in software versions 2.59.3 and earlier. This could occur when custom reference ranges were configured after device installation.
Siemens is recalling 80 Artis Q floor X-ray systems nationwide due to a cooling circuit failure that may cause insufficient cooling of the X-ray tube, resulting in automatic system shutdown.
Acumed LLC is recalling Cannulated Screws (4.0mm x 12mm) that may not have sufficient strength to hold bone fragments together, risking fracture or joint damage.
Siemens is recalling 38 Artis Q zeego X-ray systems nationwide due to a cooling circuit malfunction that may prevent adequate cooling of the X-ray tube, triggering automatic system shutdown.
Siemens Artis icono biplane diagnostic imaging systems may experience software errors affecting block movements and detector rotation, potentially delaying treatment until the system is restarted.
The Artis Q X-ray system may fail to adequately cool the X-ray tube if coolant levels drop, causing the system to disable imaging and display error messages. 418 systems are affected nationwide.
Certain Gallant VR Implantable Cardioverter Defibrillator units experience Bluetooth malfunction preventing remote monitoring and reducing battery longevity.
Siemens Artis zee biplane MN X-ray systems may have inadequate cooling in the X-ray tube circuit, causing automatic system shutdown during operation. Seven affected systems are distributed nationwide.
Qiagen Sciences' KRAS mutation testing kit can produce false positive or false negative results due to testing flags or warnings. 435 kits distributed across 16 U.S. states are affected.
Siemens SOMATOM CT scanners with software syngo CT VA30A_SP4 may experience sporadic software errors causing scanning interruptions and potential unexpected radiation doses. 547 units affected nationwide.
Siemens Artis zee ceiling X-ray systems may fail to cool the X-ray tube if the coolant level drops. The system will automatically block X-ray emissions and display warning messages to prevent equipment damage.