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
Smiths Medical ASD Inc. is recalling 2,191 Bivona Uncuffed Wire Endotracheal Tubes due to inadequate pouch seals that compromise the sterile barrier. Affected devices have 325mm shaft lengths and were distributed nationwide and internationally.
Olympus recalls ASC PneumoLiner surgical devices due to incorrect orientation of the containment bag that deploys upside down. This increases the risk of trapping bowel tissue during gynecologic laparoscopic surgery.
W L Gore & Associates is recalling 222 GORE Cardioform Septal Occluder devices labeled with a 3-year expiration date instead of the correct 2-year expiration.
W L Gore recalled 846 GORE CARDIOFORM Septal Occluder units labeled with a 3-year expiration instead of the correct 2-year expiration.
W. L. Gore & Associates is recalling GORE CARDIOFORM Septal Occluders labeled with incorrect 3-year expiration dates instead of 2-year dates. This labeling error affects devices distributed across the United States and internationally.
W L Gore & Associates is recalling GORE CARDIOFORM Septal Occluder devices labeled with a 3-year expiration date instead of the correct 2-year date. Mislabeling could result in use of devices beyond their intended safe lifespan.
GORE CARDIOFORM SEPTAL OCCLUDER devices are recalled for labeling errors: 95 units marked with 3-year expiration instead of correct 2-year date. Affected units distributed across US and international locations.
Smiths Medical recalled two Pneupac paraPac plus 300 ventilator kits distributed in the UK that were labeled with the same serial number, preventing differentiation between the two units.
W L Gore & Associates recalls GORE CARDIOFORM SEPTAL OCCLUDER devices labeled with a 3-year expiration date when the actual shelf life is 2 years. The mislabeling affects 15 units distributed across the United States and internationally.
Datascope Corp. is recalling Cardiosave Li-Ion battery packs that failed to meet minimum runtime requirements. These nonconforming batteries were inadvertently released to customers worldwide.
Smiths Medical CADD-Solis VIP ambulatory infusion pumps may fail to detect air in the infusion line and alert clinicians due to intermittent air-detector malfunction.
Philips EPIQ CVxi ultrasound systems running software versions 6.0, 7.0, or 7.0.3 may become unresponsive due to an EchoNavigator error, requiring system restart that could delay treatment.
The HemosIL Liquid Anti-Xa diagnostic assay has reduced on-board stability from 7 days to 5 days. Laboratories should follow updated stability guidelines for all currently released and future lots.
Medtronic recalls 274,991 sterile surgical blades due to complaints of tip breaks and vibration during use. The blades are components of surgical systems used in brain and ENT procedures.
Stradis Healthcare is recalling its Standard IUD Insertion Kit (280 units) after being unable to confirm the tenaculum devices meet required design and manufacturing standards.
GE Healthcare's SIGNA Architect MRI system may fail to generate complete image slices under certain software conditions, resulting in gaps within 3D volume images that could affect diagnostic imaging integrity.
GE Healthcare is recalling the SIGNA Voyager nuclear magnetic resonance imaging system due to a software issue that can cause missing slices in 3D volume images, potentially creating gaps in anatomical information.
Canon Medical System is recalling three Canon PET-CT Scanner units due to a software flaw that prevents automatic scan progression. This malfunction could cause diagnostic failures requiring unnecessary rescanning and contrast medium reinjection.
GE Healthcare's Discovery MR750 3.0T MRI system may not capture all required image slices under certain conditions, resulting in gaps in diagnostic 3D images. Five devices are affected.
GE Healthcare recalls the Discovery MR750w 3.0T MRI system. Under certain software conditions, image slices may be missing, creating gaps in 3D diagnostic images.
Siemens has recalled approximately 1,193 Atellica IM 1300 analyzers due to reagent overflow that occurs at altitudes above 350 meters, causing diagnostic test errors.
Smiths Medical is recalling CADD Administration Sets (Model #21-7346-24) distributed in Canada because the air filter may have been assembled incorrectly. This manufacturing defect could impact device function.
ADRIA SRL is recalling herniatome surgical devices used in lumbar spinal procedures due to improper sterilization. The contract sterilizer failed to follow required process parameters, potentially compromising device sterility.
GE Healthcare is recalling 5 SIGNA Pioneer MRI systems where a software issue can cause missing image slices in 3D volume scans. This may lead to diagnostic gaps.
Bard Peripheral Vascular Inc is recalling an Economy Jamshidi Bone Marrow Biopsy and Aspiration Tray due to misbranding. A total of 360 devices were distributed to healthcare facilities across multiple U.S. states.