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
Olympus tracheal intubation fiberscopes are being recalled because the manufacturer lacks adequate data confirming the suction flow rate meets device specifications. No injuries have been reported.
Ortho-Clinical Diagnostics is recalling VITROS XT 3400 Chemistry Systems due to software issues causing screen freezes and system unresponsiveness. The problems can delay reporting of patient test results, including critical or STAT assays.
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.
SagiPlan 2.2 brachytherapy treatment planning software is recalled due to a software malfunction that may round numerical values, potentially causing inaccurate treatment measurements.
The Sensica Urine Output System (SCCS1002) displays incorrect timestamps and monitoring data when connected to WiFi or internet due to a time synchronization issue. This malfunction affects the accuracy of patient monitoring records.
Meridian Bioscience is recalling Para-Pak Zn-PVA stool specimen collection vials due to a manufacturing defect that may cause leakage and risk exposure to biological hazards.
Change Healthcare's Stratus Imaging PACS software can incorrectly associate patient imaging studies with the wrong patients. Approximately 454 affected units have been distributed nationwide.
Medline Industries is recalling 1,800 units of Sterile Betadine (Ref DYNDA1998) because the foil sachet contents are non-sterile, despite labeling that claims sterility. The recall affects units nationwide in eight states.
Medline Industries recalls 300 units of Sterile Povidone (REF DYNDA2061) after discovering the solution inside foil sachets is non-sterile despite sterile labeling. Affected lots are distributed across eight states.
Limacorporate is recalling 33 PHYSICA HPS Tibial Liner units distributed in the U.S. due to incorrect product labeling. No adverse events have been reported.
Riverpoint Medical is recalling Iconix Knotless 1.4mm surgical anchors because the inserter can fail or bend when used in hard bone, potentially damaging sutures during insertion or use.
Ortho-Clinical Diagnostics recalls 216 VITROS XT 7600 laboratory systems running Software Version 3.8.0 due to software issues causing screen freezes and unresponsiveness. The defects delay test result reporting and could postpone patient treatment.
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.
Staar Surgical recalls EVO VISIAN implantable intraocular lenses because they may not meet specifications. Patients with these implants should contact their ophthalmologist.
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.
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.
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.
Integra LifeSciences is recalling 510 units of Cranial Access Kits due to a defect in outer packaging that can split spontaneously, compromising device sterility and increasing infection risk in neurosurgery.
Stryker is recalling ProCurity model 3009 patient beds because they lack required electrical safety testing, creating a risk of electrical shock or tissue burn. Affected units were distributed nationwide and internationally.
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.
Thor Photomedicine's NovoTHOR Gen 2.5 therapy beds are being recalled due to failure of ball stud components in the gas strut, which can detach from the canopy. This affects 26 units distributed across the US and internationally.
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.
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.
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.