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
Elekta recalls Infinity radiation therapy systems for a detector arm defect that could cause uncontrolled extension if a microswitch is improperly configured. No injuries reported.
Stryker ProCuity patient beds lack required electrical safety test values, posing risk of tissue burn or electrical shock to patients and healthcare workers.
IHB Operations is recalling Freedom Boom ceiling-mounted equipment dispensers due to weakened connection points on the suspension arm that could cause equipment failure. The defect affects 1,497 units distributed across multiple US states.
Heartware is providing updated instructions for the HVAD ventricular assist device to clarify Controller Fault alarm conditions and device useful life information for 892 implanted units worldwide.
Integra LifeSciences is recalling 1,639 units of its Cranial Access Kits because the outer packaging may split without additional external force, potentially compromising device sterility.
Staar Surgical Company is recalling 9 EVO VISIAN intraocular lenses due to potential specification non-compliance. The affected devices were distributed to 40 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 is recalling 485 Cranial Access Kits (Catalog INS7250) due to a packaging defect that can cause spontaneous splitting, compromising device sterility. The kits are used for surgical access to the brain.
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.
Ortho-Clinical Diagnostics is recalling certain VITROS ECO2 diagnostic slides that may produce inaccurate carbon dioxide measurements, potentially leading to misdiagnosis of acid-base balance disorders.
Integra LifeSciences is recalling a cranial access kit due to a packaging defect that can cause the sterile outer packaging to split without additional force, potentially compromising device sterility.
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.
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'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.
AURIS Health is recalling the Monarch Platform virtual bronchoscope due to potential software issues that may flip the displayed surgical image, which could impair visualization during minimally invasive procedures.
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.
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.
Stryker Medical is recalling ProCuity hospital beds with missing electrical safety test documentation, creating risk of electrical shock or tissue burns.
CooperSurgical is recalling H/S ELLIPTOSPHERE CATH 5 FR Sets (169 units) due to incorrect bonding material that may cause component detachment or leakage, potentially delaying diagnostic procedures.
Integra LifeSciences is recalling 59 Integra Cranial Access Kits due to outer packaging that can split without external force, compromising device sterility. Affected units (Lot 6837706, exp. 1-Mar-25) should be discontinued immediately.
Elekta is recalling 264 units of its Synergy Platform radiation therapy systems due to a microswitch defect that could cause uncontrolled extension of detector arms. The systems were distributed worldwide.
Wilson-Cook Medical is recalling QUANTUM TTC BILIARY BALLOON DILATORS due to nonconforming devices that may detach during use. Detachment could require endoscopic retrieval and carries a risk of bleeding.
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.
Carestream Health is recalling the DRX Revolution Mobile X-Ray System due to unexpected failure of electrical components in the CPI generator. The recall affects approximately 3,961 units distributed worldwide.