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
American Contract Systems, Inc. is recalling the Hand Pack AKHD97C medical convenience kit because an inoperable chart recorder caused humidity readings to fall outside specifications, preventing confirmation of sterilization assurance.
Cook Biotech is recalling 3 units of Biodesign Fistula Plug surgical implants because they expire before the printed expiration date. The devices were distributed worldwide.
Roche Diagnostics is recalling Creatine Kinase test reagents that may exhibit abnormal calibrations, producing inaccurate results. Lot 755471 distributed nationwide.
Boston Scientific is recalling WallFlex and Agile esophageal stent systems due to potential for delivery catheter tip detachment during insertion.
Boston Scientific is recalling Wallflex and Agile esophageal stent systems worldwide due to the potential for delivery catheter tip detachment during placement. The recall affects 133 units distributed globally.
The BD Phoenix M50 instruments may misidentify Escherichia coli (E. coli) in clinical samples, potentially causing misdiagnosis and inappropriate treatment. About 4,295 affected units were distributed worldwide.
CooperSurgical is recalling Origio Sperm Wash Medium due to low sodium pyruvate concentration. The deficiency could compromise gamete development in assisted reproductive procedures.
American Contract Systems is recalling 3 units of the COPM11B pacemaker medical kits due to inability to confirm sterilization requirements were met. An inoperable chart recorder caused humidity readings to exceed specifications during manufacturing.
Siemens ACUSON Redwood ultrasound systems may display measurements 10 times smaller than actual if operators change the software from factory defaults to milliliters per second or minute. This could lead to misdiagnosis and poor patient management.
American Contract Systems is recalling the Essentia MAJ Laparotomy Std Pack because an equipment failure prevented confirmation of sterilization requirements for this medical convenience kit.
Ultrasonic cleaner solutions contaminated with pathogenic bacteria may cause serious infections if used in medical or dental procedures, and may leak or become bloated. Patients and healthcare workers handling the products are at risk.
Boston Scientific Corporation is recalling WallFlex Esophageal Stent Systems and Agile Esophageal Over-the-Wire Stent Systems due to potential delivery catheter tip detachment during insertion procedures.
American Contract Systems, Inc. is recalling the Vaginal Delivery ASDV25B medical convenience kit due to an inoperable chart recorder that prevented confirmation of sterilization assurance. The device may not meet required sterilization standards.
Siemens ACUSON Maple ultrasound systems may perform incorrect unit conversion in software, producing values 10 times smaller than actual. This could lead to misdiagnosis or inappropriate patient management.
The FDA is recalling LINK Universal Handles due to risk of material failure when first used. The surgical instrument may break during surgery, compromising patient safety.
Boston Scientific is recalling the Wallflex Esophageal Stent System and Agile Esophageal Over the Wire Stent System due to potential delivery catheter tip detachment during placement. Wallflex devices totaling 115 units are affected.
Philips recalls certain Ingenia 1.5T MRI devices due to loose assembly screws that may block the patient tabletop, potentially delaying diagnosis and causing patient anxiety.
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.
Hologic is recalling Selenia Dimensions and 3Dimensions software due to a defect that may cause blurry images and potential misdiagnosis.
Wipro GE Healthcare is recalling specific GE Giraffe Warmers because incomplete electrical safety testing during manufacturing may allow leakage current to exceed safety limits.
Karl Storz Hopkins Telescope 6 endoscopes are recalled because their Instructions for Use contain reprocessing methods that lack FDA review and approval.
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 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.
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.