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
Medline Industries has recalled approximately 19,406 leg bags due to undeclared latex. Patients with latex allergies may experience allergic reactions from skin contact with the device.
Spectranetics Corporation is recalling 1,239 Turbo-Elite Laser Atherectomy Catheters due to incorrect labeling where the exterior product box label does not match the internal pouch label.
APN Health LLC is recalling the Navik 3D v2 3D Mapping System to update the product instructions for use. The firm initiated this voluntary recall.
The FDA is recalling CARDIOHELP Emergency Drive units due to potential blocking that impairs blood flow. Affected patients may experience ischemia and hypoxia from inappropriate low blood oxygen.
B. Braun Infusomat Administration Sets may have incorrect tubing dimensions that cause false air-in-line alarms, interrupting medication delivery. The defects may prevent critical medications from reaching patients.
Stryker Medical is recalling ProCuity hospital beds with missing electrical safety test documentation, creating risk of electrical shock or tissue burns.
Thor Photomedicine is recalling six THOR NOVO GEN 2.0 XL whole body red light therapy beds due to ball stud component failure. The defect causes gas strut detachment, making the canopy difficult to lift.
Stryker is recalling ProCuity patient beds (model 3009) for missing electrical safety test values, which presents risk of electrical shock or tissue burn.
Integra LifeSciences is recalling 180 Cranial Access Kits due to a packaging defect that can cause splits, compromising the sterility of the surgical device.
The Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr catheter may detach or leak due to defective bonding material used in assembly. The 73 affected units were distributed nationwide and internationally.
Wilson-Cook Medical is recalling QUANTUM TTC biliary balloon dilators due to design non-conformance. The devices may detach during use, potentially requiring endoscopic retrieval that could cause bleeding.
CardioQuip Modular Cooler-Heater units are being recalled due to a potential heating-chamber malfunction that could cause melting and burning of internal components. 125 units distributed across 15 US states are affected.
Staar Surgical is recalling 20 units of the EVO+VISIAN Implantable Collamer Lens due to a potential that implanted devices may not meet specifications. The recall affects units distributed across multiple US states.
Vyaire's Flexible Patient Circuits (29028-004) for the 3100A ventilator were distributed in the U.S., despite being approved only for use outside the U.S. They do not meet U.S. regulatory requirements.
Integra LifeSciences Corp. is recalling 173 units of its Cranial Access Kit due to a packaging defect that can split and compromise device sterility. No illnesses have been reported.
Staar Surgical is recalling 15 EVO+VISIAN Implantable Collamer Lens devices due to potential specification failures. The devices may not meet design specifications.
Staar Surgical recalls EVO VISIAN implantable intraocular lenses because they may not meet specifications. Patients with these implants should contact their ophthalmologist.
Staar Surgical recalls six EVO+VISIAN intraocular lens implants due to potential specification non-compliance. The affected units were distributed across 38 US states.
Recall of approximately 1,019 Elekta Synergy radiation therapy systems due to potential uncontrolled extension of detector arms if the middle arm microswitch is incorrectly setup.
Encore Medical is recalling 37 DJO surgical EMPOWR Porous Knee System SIZE 8 devices distributed nationwide because incorrect product components were packaged with certain units.
Abiomed is recalling Automated Impella Controller units with software versions V8.4 and V8.4.1 because a software issue may prevent proper pump connection detection. Affected devices were distributed in Arizona, California, Florida, New York, and Virginia.
CooperSurgical H/S Catheter Sets may have defective bonding material causing component detachment or leakage. The sets are used in hysterosalpingography procedures to detect uterine abnormalities.
Stryker ProCuity beds (model 3009) are missing electrical safety test values, presenting risks of electrical shock and tissue burns. FDA Class II recall.
HeartWare is updating documentation for 380 HVAD cardiac assist devices to clarify Controller Fault alarm conditions and device lifetime instructions.
Staar Surgical recalls 51 EVO+VISIAN intraocular lenses due to potential specification non-compliance. Affected devices were distributed across multiple U.S. states.