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
GE Healthcare is recalling three ViewPoint imaging systems due to a software vulnerability in Mirth Connect that could allow unauthorized access and manipulation of patient data.
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized pneumatic tubing in the reagent storage module, which can cause air leaks and compressor failures, potentially leading to test errors and delayed results.
Boston Scientific is recalling 89 units of Flexima APDL Drainage Catheter Systems because holes in the sterile barrier may compromise device sterility.
B Braun Medical Inc. is recalling Streamline Bloodline Sets because incomplete connector insertion may cause flow restrictions during hemodialysis.
B Braun Medical is recalling hemodialysis bloodline tubing because the patient connector may not fully insert into the device, potentially blocking blood flow and delaying treatment. Affected units were distributed nationwide.
Safeguard US Operating LLC is recalling the HAWK Warming Grid (Item 59-300) due to an incorrect expiration date. The affected units may not function safely if used beyond the actual expiration date.
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.
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.
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.
Philips is recalling 109 MultiDiagnost Eleva X-ray systems worldwide due to potential cable hose carrier detachment from broken plastic or bolts, which could cause parts to fall and 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.
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.
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.
Mazor Robotics is recalling 94 Mazor X surgical navigation devices due to software errors that cause screen lag or screw-tracking mismatches during orthopedic procedures.
CareFusion's Alaris System PC Unit Model 8015 infusion pumps are being recalled due to a bent female IUI connector affecting over 125,000 devices. The defect may prevent the device from operating properly or delay infusion or monitoring startup.
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.
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.
Smiths Medical ASD Inc. is recalling Pneupac paraPAC plus 300 ventilator kits because the tidal volume knob may move from its original setting.
Smiths Medical is recalling approximately 12,234 BLUselect, BLUgriggs, and BLUperc tracheotomy tube kits due to a manufacturing defect that may cause the pilot balloon to disconnect from the inflation line.
Olympus Corporation recalled 2,525 electrosurgical knives (KD-645L) nationwide after reports of serious injury from knives breaking off during use. Users must follow Instructions for Use regarding proper electrosurgical unit compatibility and output settings.
Smiths Medical ASD Inc. is recalling 10,240 Pneupac paraPAC plus 310 ventilator kits due to risk of unintended tidal volume knob movement, affecting all serial numbers worldwide.
Smiths Medical is recalling select BLUSelect tracheostomy tubes due to a manufacturing defect that could cause the pilot balloon to disconnect from the inflation line. No injuries have been reported.
Medline is recalling ER Suture Convenience Kits because the included plastic syringes have leaks, breakage, or other quality issues that may pose a risk to patient health.
Olympus Corporation recalls 4,507 Triangle Tip Electrosurgical Knives (Model KD-640L) due to device fragmentation during use. The issue is linked to reports of serious injury and improper adherence to usage instructions.
B Braun is recalling the Infusomat Space Infusion Pump due to a sensor malfunction that can trigger false alarms, risking improper medication delivery.