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
Stryker Medical is recalling ProCuity bed series model 3009 due to missing electrical safety test values. The beds pose a risk of electrical shock or tissue burn to patients.
Integra LifeSciences is recalling the Integra Cranial Access Kit due to a defect in the outer packaging that can split and compromise device sterility. A total of 173 units are affected.
Stanbio Laboratory is recalling STAT-Site M BHB Test Strips due to stability deterioration that causes false negative results. This defect may delay diagnosis and treatment of patients with conditions such as diabetic ketoacidosis.
Heartware is updating instructions for the HVAD ventricular assist device to clarify controller fault alarm conditions and component useful life guidance for 126 units distributed worldwide.
Staar Surgical recalls EVO VISIAN implantable intraocular lenses because they may not meet specifications. Patients with these implants should contact their ophthalmologist.
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 is recalling ProCurity patient beds (model 3009) due to missing electrical safety test documentation. Affected beds pose a risk of electrical shock or tissue burns. Facilities should verify their bed serial numbers and contact Stryker.
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.
Stryker ProCuity patient beds lack required electrical safety test values, posing risk of tissue burn or electrical shock to patients and healthcare workers.
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.
Wilson-Cook Medical Inc. is recalling 888 units of the Quantum TTC Biliary Balloon Dilator due to design nonconformance that could cause balloon detachment during use, potentially requiring endoscopic retrieval or causing bleeding.
Stryker is recalling ProCuity patient beds (model 3009) for missing electrical safety test values, which presents risk of electrical shock or tissue burn.
Staar Surgical is recalling 11 EVO+VISIAN implantable collamer lenses distributed across 38 US states because they may not meet manufacturing specifications. No illnesses or injuries have been reported.
Thor Photomedicine is recalling 26 NovoTHOR Gen 2.5 XL red light therapy beds due to ball stud component failure that can cause the gas strut to detach, making the canopy difficult to lift.
Wilson-Cook Medical is recalling 941 biliary balloon dilators that may detach during use. Detachment could require doctors to retrieve the device with an endoscope, which may cause bleeding.
CardioQuip is recalling 150 units of its Modular Cooler-Heater (Model MCH-1000m) due to potential heating-chamber malfunction that could cause component melting or burning. The device may overheat unexpectedly.
Elekta radiation therapy accelerators may experience uncontrolled detector arm extension due to an incorrectly set microswitch in the middle arm. The issue affects 315 units worldwide.
Wilson-Cook Medical recalled 731 QUANTUM TTC biliary balloon dilators due to design nonconformity that could cause balloon detachment. The device failure may require endoscopic retrieval and risks bleeding complications.
Atrium Medical Corporation is recalling 2,460 units of the Atrium Firm PVC Thoracic Catheter 36FR Straight due to sterilization nonconformance that caused premature product aging and inaccurate expiration dating. Facilities in 14 U.S. states are affected.
Atrium Medical Corporation is recalling specific lots of Atrium Oasis Dry Suction Water Seal Chest Drains that were re-sterilized by a third party using unapproved methods and packaging. The invalid sterilization process lacks manufacturer validation and may compromise device sterility.
Stryker is recalling ProCuity bed series model 3009 because they are missing electrical safety test values, presenting a risk of tissue burn or electrical shock to patients.
Heartware recalls HVAD ventricular assist pump instructions to clarify controller fault alarm conditions and component useful life expectations.
HeartWare is issuing clarifications to instructions for the PUMP 1103 HVAD ventricular assist device regarding when Controller Fault alarms sound and component useful life. No illnesses or injuries have been reported.
Elekta recalled its ELEKTA AXESSE radiation therapy system due to potential uncontrolled extension of detector arms if the microswitch is incorrectly configured. The recall affects 47 units distributed worldwide.
Stryker's ProCuity hospital beds (model 3009) lack electrical safety test values, creating a risk of tissue burns and electrical shock to patients. The beds were distributed nationwide and internationally.