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 anomaly in the Merlin PCS 3650 programmer may cause an in-clinic pacing test to fail terminating and prevent restoration of the implanted device's normal settings. Approximately 30,069 affected devices have been distributed worldwide.
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.
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.
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.
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 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.
St. Jude Medical's Gallant DR implantable cardioverter defibrillator has a Bluetooth malfunction preventing remote monitoring and reducing battery life. The device enters inductive-only telemetry mode, requiring in-clinic monitoring instead.
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.
Resource Optimization & Innovation LLC is recalling 3,570 Regard IV Start Kits due to a recalled component, the PDI Prevantics Swab. The affected kits were distributed to two consignees in Missouri.
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.
GE Healthcare MRI systems may fall during magnet de-installation if rigging and hardware are not properly installed and secured, creating a potential injury hazard.
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.
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.
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.
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.
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.
Siemens is recalling 183 Artis zeego X-ray imaging systems due to a cooling system defect that may prevent adequate X-ray tube cooling, 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.
Terumo Cardiovascular Systems Corp is recalling two lots of cardiovascular procedure kits due to packaging damage that occurred during shipping. The recall affects 64 units distributed in California and Indiana.
Abbott is recalling 2,134 TactiCath ablation catheters manufactured with a preprogrammed 'First Use Date' that disables the device. Affected devices with 37 specific lot numbers were distributed in the U.S. and 21 other countries.
Microbiologics Inc is recalling an inactivated Mycoplasma genitalium reference material (Catalog # HE0070N, Lot HE0070-01-1) because the quality control process did not meet specification requirements.
Baxter is recalling DISCPAC syringe tip caps that are mislabeled as self-righting when they do not possess this capability, risking improper use in medical procedures.
Microbiologics Inc recalls an inactivated Mycoplasma genitalium reference standard (Lot HE0069-02-1) because its quality control process did not meet specification requirements. This reference material is used in diagnostic and laboratory testing.
Siemens is recalling Artis zee floor MN X-ray systems due to a potential cooling circuit malfunction. If coolant drops below adequate levels, the X-ray tube may not cool properly and the system will automatically shut down.