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
Karl Storz Hopkins Telescope 6 endoscopes (59 units, nationwide) are recalled because their reprocessing instructions lack FDA review and approval for safety and efficacy.
Boston Scientific is recalling WallFlex and Agile esophageal stent systems due to potential delivery catheter tip detachment during stent placement procedures.
Cook Biotech is recalling the Biodesign Fistula Plug implant because devices expire before their labeled expiration dates. Thirty-nine units distributed worldwide are affected.
Fujifilm mobile x-ray systems may fail to apply configured exposure settings or default to adult chest imaging parameters. This could result in inappropriate radiation exposure levels.
Philips SmartPath dStream MRI devices have loose screws in the RF carrier assembly that may interfere with the moving tabletop, potentially delaying diagnosis. Affected units should be inspected and repaired immediately.
GE Panda iRES infant warmers may have incomplete electrical safety testing that could cause leakage current to exceed safe limits. The company is recalling 137 units distributed in the US and internationally.
Philips is recalling 68 MR 5300 MRI diagnostic systems worldwide because loose screws in the RF carrier assembly could block equipment movement and delay patient diagnosis.
Cook Biotech is recalling 3 units of Biodesign Recto-Vaginal Fistula Plug RVP-0.2 because the devices expire prior to the expiration date printed on the labeling.
Boston Scientific has recalled AGILE and WallFlex esophageal stent systems due to potential delivery catheter tip detachment. This defect could occur during stent deployment and affect proper stent placement.
Boston Scientific is recalling WallFlex and Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The recall affects 231 units distributed worldwide.
Centinel Spine is recalling the Prodisc C SK cervical disc implant due to blue discoloration identified as foreign contamination on the inlay during assembly. The contamination was not fully evaluated in manufacturing validations.
Argon Medical Devices recalls BioPince Ultra and Tru-Core II biopsy instruments due to holes in packaging trays compromising the sterile barrier, which may allow microorganism introduction and infection risk.
Assembly screws in Philips Ingenia Ambition S MRI systems may loosen and protrude, potentially blocking the patient tabletop and delaying diagnosis. Philips is recalling 64 affected units worldwide.
Baxter is recalling EXACTAMIX compounding device inlets due to particulate matter observed in sterile fluid pathways before use. Approximately 5.8 million units affected worldwide.
Baxter Healthcare Corporation is recalling EXACTAMIX Inlet components due to particulate matter found in sterile fluid path tubing. Approximately 1.5 million units were distributed worldwide.
Baxter Healthcare is recalling EXACTAMIX Inlet components (H938173 and related codes) due to particulate matter contamination observed in the sterile fluid path before use. Approximately 3.58 million units distributed worldwide are affected.
Baxter Healthcare is recalling ExactaMix pharmaceutical compounding device inlets due to increased reports of particulate matter in the sterile fluid path before use. The recall involves 2,140,046 units with worldwide distribution.
Boston Scientific is recalling VTC Regular Kit Nephrostomy Catheter System kits due to potential holes in the sterile barrier of the device pouch, which may compromise device sterility.
Tornier, Inc. is recalling one lot of the Stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS shoulder implant due to bacterial endotoxin exceeding safety specifications. The 5 affected units were distributed in Illinois, Wisconsin, Arizona, Nevada, and South Dakota.
Philips Allura Xper FD series fluoroscopy systems may have detached cable hose carriers due to broken plastic or bolts. A detachment could cause parts to fall and potentially result in injury.
B. Braun is recalling 9,864,165 Streamline Bloodline Sets nationwide due to incomplete patient connector insertion. The defect may restrict fluid flow during hemodialysis and cause therapy delays.
Boston Scientific is recalling Flexima Regular Kit Nephrostomy Catheter System kits due to potential holes in the sterile barrier pouch that may compromise device sterility.
Medtronic is recalling CareLink 2090 Programmers (serial number prefixes PKK0 and PKK1) worldwide due to potential autonomous cursor motion when Finger Touchscreen capability is enabled with software version 3.2 or higher. Approximately 18,788 units are affected.
Siemens Healthcare's ADVIA Chemistry Microalbumin diagnostic test may produce falsely low results. Eight lots do not meet High-Dose Hook Effect and Prozone Effect specifications, potentially affecting microalbumin detection accuracy.
Boston Scientific is recalling Flexima Biliary Catheter System Kit (Lot #33512376) due to potential holes in the device pouch's sterile barrier, which could compromise device sterility. No illnesses or injuries have been reported.