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
Wilson-Cook Medical recalls 553 Quantum TTC Biliary Balloon Dilators that do not meet design specifications, creating risk of balloon detachment during endoscopic procedures.
Staar Surgical is recalling 133 units of EVO+VISIAN intraocular lenses that may not meet manufacturing specifications. The affected devices were distributed across multiple U.S. states.
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.
Abiomed is recalling Automated Impella Controller (AIC) software versions V8.4 and V8.4.1 due to a software issue that may prevent the pump from being detected as connected to the controller. Devices were distributed in Arizona, California, Florida, New York, and Virginia.
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.
Thor Photomedicine is recalling 19 NovoTHOR Gen 2.0 red light therapy beds due to ball stud component failures that can cause canopy detachment or difficulty in lifting. The beds were distributed worldwide.
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.
Heartware is updating instructional materials for the HVAD ventricular assist device to clarify when Controller Fault alarms sound and how to troubleshoot them. Updates also address component useful life instructions.
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.
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 ProCuity patient beds lack required electrical safety test values, posing risk of tissue burn or electrical shock to patients and healthcare workers.
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.
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.
Heartware recalls HVAD ventricular assist pump instructions to clarify controller fault alarm conditions and component useful life expectations.
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.
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.
Staar Surgical recalls EVO VISIAN implantable intraocular lenses because they may not meet specifications. Patients with these implants should contact their ophthalmologist.
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.
Luminex Corporation is recalling 222 kits (4,440 VERIGENE BC-GP Utility Trays) used in blood culture testing due to potentially defective utility trays. The affected lot (062123018C) expires December 20, 2023.
Vyaire Medical recalled 188 Flexible Patient Circuit 3100A units distributed in Florida that were approved only for use outside the United States. The circuits were mistakenly distributed in the U.S. market.
Liberty Medical Solutions is recalling 473 Multi-Mode TENS stimulator units distributed in five states due to missing warnings and contraindications in instruction manuals.
BioFire Diagnostics is recalling BIOFIRE Blood Culture Identification 2 (BCID2) Panels due to instrument characteristic changes that cause Candida tropicalis to be detected but reported as 'Not Detected' in quality control testing.
The FDA is issuing updated instructions for the HeartWare HVAD ventricular assist device to clarify when controller fault alarms sound and when device components should be replaced. No patient harm has been reported.
Heartware is updating instructions for HVAD ventricular assist device implant kits to clarify Controller Fault alarm conditions and troubleshooting steps, as well as useful life information for system components.
Remington Medical is recalling drainage bags (Lot 2325111) due to errors in the 'Use by Date' and 'Date of Manufacturer' on box labels. Approximately 3,080 units distributed in PA and FL are affected.