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 the agency’s own highest classification or reported deaths or serious injuries, 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.
W L Gore & Associates is recalling 187 units of GORE CARDIOFORM Septal Occluders because they are labeled with a 3-year expiration date instead of the correct 2-year expiration date. Using the device beyond its actual shelf life could compromise its safety and effectiveness.
AB SCIEX's Cliquid MD version 3.4 software may incorrectly calculate Internal Standard concentrations when users hide or leave the IS column empty in customized LC-MS/MS tests, potentially leading to incorrect analytical conclusions.
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.
Medical Action Industries recalls Central Line Dressing Change kits because the ChloraPrep 3ml component expires sooner than the kit label indicates. Users should discontinue use and contact their supplier.
Implant Resource Inc is recalling the MPR Slotted Mallet (Model MPR-1120-1000, Lot 200911-1-1) due to potential separation of the mallet head from the handle and unexpected deformations on the striking surface.
GE Healthcare is recalling Optima MR450w 1.5T MRI systems due to a software issue in version DV29.1 that may cause missing image slices, creating gaps in 3D scans that could affect diagnostic accuracy.
Siemens Healthcare Diagnostics is recalling Atellica IM 1600 analyzers that may leak reagent when located at altitudes above 350 meters, potentially causing testing errors.
DiaSorin Molecular is recalling the SIMPLEXA COVID-19 Positive Control Pack due to unapproved raw materials in manufacturing that may cause delayed amplification signals during testing.
Smiths Medical ASD Inc. is recalling the Portex Loss of Resistance Device because product labeling lacks information on sterilization procedures and does not prohibit reuse. The recall affects 3,420 devices distributed internationally.
Stradis Medical recalled 14,959 IUD Insertion Kits nationwide after being unable to confirm the tenaculum devices were manufactured according to required design and manufacturing standards.
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.
Medtronic is recalling surgical blades used in ENT procedures due to increasing complaints of tip breaks and vibration. Approximately 274,991 devices distributed worldwide are affected.
Smiths Medical is recalling over 933,000 medfusion Stopcock medical devices internationally due to lack of sterility assurance. The devices may not meet required sterility standards.
Fort Defiance Industries is recalling the P2131 Automated Field Steam Sterilizer because the rear heater assembly lacks sufficient electrical grounding, creating a shock hazard. The recall affects 380 devices distributed nationwide and to Canada.
GE Healthcare recalls 18 SIGNA Artist MRI systems with a software defect that may cause missing image slices, creating gaps in 3D scans that could affect diagnostic accuracy.
GE Healthcare is recalling 11 SIGNA Premier MRI systems. Under certain conditions, software versions RX29.1 and RX27.3 can cause missing slices in 3D imaging, creating gaps in anatomical data clinicians use for diagnosis.
ADRIA SRL recalls Herniatome cervical surgical instruments (Model 5091749) due to sterilization process parameter failures. Products distributed to NJ and NY.
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.
Kinsman Enterprises is recalling approximately 13,123 Easi-Care Gait Belts because the metal buckle may fail at loads below the labeled 600-pound capacity, creating a fall risk for users.
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.
Stradis Medical recalled 790 Foundation Kits because the manufacturer cannot confirm tenaculum devices met design and manufacturing standards.
GE Healthcare is recalling the 1.5T SIGNA HDxt MR System due to a software issue that may cause missing slices in 3D volume images. Three devices distributed across the United States and internationally are affected.
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.