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
Chamberlain Technologies LLC is recalling SURGIMESH XB surgical mesh due to potential residual adhesive material on the mesh surface. The affected product was distributed to Illinois, Nebraska, and California.
ICU Medical is recalling Plum Duo infusion pumps with software version 1.1.1 because a workflow may bypass the Maximum Dose Limit alert, potentially allowing unsafe medication doses to be programmed.
Ohio Medical Corporation is recalling 36 units of the GCE HEALTHCARE Zen-O lite portable oxygen concentrator due to erroneous calibration values that may cause the device's alarm for low oxygen purity to function incorrectly as the device ages.
Siemens is recalling UROSKOP Omnia Max medical devices due to a resistor in the frequency inverter that may overheat and ignite the plastic housing. Twenty-five units distributed nationwide are affected.
ICU Medical is recalling Plum Solos infusion pumps (Item 400011001) with software version 1.1.1 due to a workflow that may bypass the Maximum Dose Limit alert, which is designed to prevent overdose. The defect affects 214 units distributed across nine US states and the Philippines.
BALT USA is recalling the Optima Coil System because the radiopaque marker was not visible during angiography and was not manufactured to specification.
BALT USA is recalling Prestige Coil System implantable embolization devices because radiopaque markers on some units were not manufactured to specification and were not visible during angiography.
Spectral Instruments Inc is recalling the Ami HTX X-ray instrument because the safety and manufacturing date labels do not match FDA requirements.
Pluslife SARS-CoV-2 Card nucleic acid testing kits were distributed in the U.S. without required FDA premarket authorization. The FDA is recalling approximately 1,850 boxes distributed nationwide and internationally.
Chamberlain Technologies LLC is recalling SURGIMESH WN polymeric surgical mesh due to potential residual adhesive material on the mesh surface. The recall affects 20 units distributed to Illinois, Nebraska, and California.
Spectral Instruments Inc is recalling the Lago X X-ray instrument because its safety and manufacturing date labels do not match FDA requirements.
Chamberlain Technologies is recalling SURGIMESH XB surgical mesh due to potential residual adhesive material on the mesh surface. The product was distributed to facilities in Illinois, Nebraska, and California.
Chamberlain Technologies LLC is recalling SURGIMESH WN Polymeric Surgical Mesh due to potential residual adhesive material on the mesh surface. The 60-unit recall affects medical facilities in Illinois, Nebraska, and California.
Guangzhou Pluslife Biotech is recalling the MiniDock Integrated Nucleic Acid Testing Device (Model PM001) because it was distributed in the U.S. without required FDA premarket authorization.
Diagnostica Stago is recalling STA-Owren Koller buffer solution (Lot 270902) because it may produce shorter clotting times in certain tests, potentially leading to a 1% overestimate of clotting results.
Hangzhou AcoSound Technology Co., Ltd. is recalling 120 units of the AcoSound Model LW12-BTE-M hearing aid due to labeling errors, including incorrect manufacturer attribution, missing manufacturer business address, and incomplete UDI information.
Medtronic Azure S DR MRI SureScan pacemakers may experience sudden battery power failure without warning, potentially interrupting therapy and leading to cardiac arrest or hospitalization. Affected devices are being recalled internationally.
Zyno Medical LLC is recalling 613 units of the Z-800 Infusion System distributed nationwide because unreleased software versions were installed on the devices without verification or validation.
Philips is recalling one Intera 1.5T Achieva IT Nova MRI system due to a gradient coil component that may overheat and produce smoke or fire, posing risks of inhalation injury, burns, or death.
Philips SmartPath to dStream for 1.5T MRI systems are recalled due to potential gradient coil component failure that may produce smoke and fire, posing risks of inhalation injury, burns, asphyxia, and death.
Philips is recalling three Intera 1.5T Achieva Nova-Dual MRI systems worldwide due to a gradient coil component failure that can generate smoke and fire, posing risks including burn injury and asphyxia.
Zyno Medical LLC is recalling 613 units of the Z-800WF Infusion System because unreleased software versions were installed on distributed devices without verification or validation.
Philips is recalling certain Intera 1.5T Achieva Nova MRI systems due to a gradient coil component that can overheat, potentially causing smoke or fire with risk of burns, smoke inhalation, or asphyxia.
Philips Achieva XR MRI systems may have a gradient coil component failure that can generate heat, smoke, and fire. The risk to patients and operators includes inhalation of smoke, burns, and asphyxia.
Philips Medical Systems has recalled Azurion R1.x and R2.x X-ray systems worldwide due to a software issue that can cause loss of imaging functionality and delay treatment, potentially resulting in serious harm or death in patients undergoing urgent or complex interventions.