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
Siemens Healthcare's Aptio Automation Interface Module firmware may incorrectly associate test results with the wrong sample IDs, potentially affecting clinical decision-making.
FujiFilm Healthcare is recalling Arietta 750 Ultrasound Software versions V1.0.0 through V2.1.3 due to measurement display errors in critical cardiology functions that could lead to incorrect clinical diagnoses. The instruction manual also contains an error.
Siemens is recalling Atellica IM SARS-CoV-2 Antigen Assay kits because validation data submitted to the FDA was insufficient to confirm the assay's accuracy for its intended use.
FujiFilm Arietta 850 ultrasound systems with affected software versions display cardiology measurement results incorrectly. The recall affects 38 units distributed nationwide.
Bayer Medical Care is recalling 6,950 units of MEDRAD Twist & Go Disposable Syringes due to labeling errors that could cause confusion about syringe compatibility with the MEDRAD Mark 7 Arterion Injection System.
Implant Direct Sybron Manufacturing is recalling 83 dental implants from lot 166300 because the implants differ in size from what is labeled on the packaging. The implants were distributed across multiple US states and Japan.
Karl Storz FIVE S 3.5x65 flexible intubation videoscopes failed sterility assurance testing. The recall affects 532 units distributed across the US and Canada due to infection risk.
Lisendo 880 Ultrasound Software versions V1.0–V4.1.3 may not display cardiac measurement results correctly for mitral valve assessments, affecting diagnostic accuracy.
Cook Inc. recalls Flexor Check-Flo Introducer Sets where the radiopaque marker band is incorrectly positioned, which may not be discovered until the device is used in a patient under fluoroscopy, increasing procedural time.
Medtronic recalled the Clinician Programmer Application (CPA) model A610 due to a potential software anomaly. Affected versions 3.0.1048, 3.0.1057, 3.0.1062, and 3.0.1081 have been distributed worldwide. No illnesses or injuries have been reported.
Cook Inc. is recalling one lot of Flexor Check-Flo Introducers due to a manufacturing defect where the radiopaque marker band may be positioned incorrectly, affecting visualization during medical procedures.
MicroVention's Aspiration Syringe Kit (REF: MVSK60) was labeled for international distribution but inadvertently shipped to U.S. customers. The affected lot (H2146461) was distributed to Alabama, Nevada, and New York.
ROSA One 3.1 surgical guidance system recalled due to a software anomaly causing inaccurate electrode placement during brain and spine surgery. Manufacturer received 3 complaints related to the issue.
W.L. Gore is recalling 138 units of GORE Cardioform Septal Occluder devices labeled with a 3-year expiration date instead of the actual 2-year shelf life.
Xstrahl's Concerto software used in X-ray therapy systems may fail to update treatment parameters for a second beam when a treatment plan is edited. This could result in error messages and incorrect treatment delivery.
Potomac River Group recalls 62 RAPTAR Laser Range Finders (Model G02) nationwide. The devices can be field-modified to enable higher-power visible and infrared lasers, posing eye injury risk from uncontrolled laser radiation.
W L Gore recalled 846 GORE CARDIOFORM Septal Occluder units labeled with a 3-year expiration instead of the correct 2-year expiration.
Siemens Healthcare is recalling Atellica CH Urinary/Cerebrospinal Fluid Protein reagent due to potential carryover causing falsely depressed Hemoglobin A1c results that may affect clinical decision-making.
Medtronic is recalling 591 units of C315-HIS Delivery Catheters due to reports that a lead cannot pass through the catheter. The catheters were distributed internationally to multiple countries, and healthcare providers should contact Medtronic for guidance.
W.L. Gore & Associates is recalling 2,238 GORE CARDIOFORM SEPTAL OCCLUDER 30 mm devices labeled with a 3-year expiration date instead of the actual 2-year expiration date.
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.
Siemens is recalling Advia Chemistry Urinary/Cerebrospinal Fluid Protein reagent due to potential reagent carryover that may cause falsely depressed Hemoglobin A1c results, which could affect clinical decisions about patient treatment.
Elekta's Oncentra Brachy versions 4.0+ may calculate incorrect doses for two-channel ovoid applicators in certain circumstances. Approximately 1,072 devices distributed worldwide.
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.
Smiths Medical is recalling 7136 Bivona Aire-Cuf Endotracheal Tubes due to inadequate pouch seals that compromise the sterile barrier. The issue affects specific lot numbers with 325mm shaft length.