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
Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products LH Reagent Pack due to low-end imprecision that may produce falsely high or delayed patient and quality control results.
The FDA is recalling 59 units of HeartWare HVAD System Controller due to translation errors in Finnish and Turkish in device displays and critical documentation including patient manuals and emergency responder guides.
Specific lots of VITROS FSH, LH, and Prolactin reagent kits may produce falsely high or delayed test results at low measurement levels. Affected lots distributed worldwide; labs should discontinue use and contact the manufacturer.
Baxter Healthcare is recalling 11,028 NaviCare Nurse Call Systems distributed in North Carolina and Virginia due to a firmware memory leak in a supplier-manufactured component.
HeartWare is recalling 645 units of HVAD Ventricular Assist Device documentation due to translation errors in Finnish and Turkish. The errors affect controller displays, patient manuals, and emergency responder guides.
Boston Scientific is updating instructions for the EXALT Model D Single-Use Duodenoscope to highlight the known risk of perforation during use and provide best clinical practices for insertion, advancement, and removal.
Randox Laboratories has recalled the CK MB Calibrator (lot 4410CK) because it requires recalibration. When used without proper realignment, the calibrator produces test results approximately 6% higher than actual values.
Convenience kits containing Prevantics swabs used in medical procedures are being recalled because the manufacturer failed to adequately validate the manufacturing test methods used during production.
Medtronic is recalling instruction materials for the HeartWare HVAD ventricular assist device due to errors and inconsistencies in product documentation.
Getinge USA is recalling 127 Washer Disinfector models worldwide due to inadequate documentation verifying proper installation. The issue could lead to installation failures and potentially hazardous situations.
Heartware is recalling 667 units of the HVAD System Controller (Model 1407DE Kit) due to translation errors in Finnish and Turkish in controller and monitor displays, as well as user documentation, which could affect patient understanding and emergency responder guidance.
Luminex Corporation is recalling a lot of VERIGENE Nucleic Acid Test Kit extraction trays due to missing reagent causing increased internal control failures. Affected lot: 101321021B, 984 units distributed in the US.
Boston Scientific updated instructions for the EXALT Model D Single-Use Duodenoscope to address the known risk of duodenal perforation and provide best clinical practices for proper insertion, advancement, and removal of the device.
Total Resources International is recalling 891 First Aid Kits due to a potential cross-contamination issue from a manufacturing equipment breach. The kits contain electrolyte tablets that may have been exposed to pharmaceutical contaminants below therapeutic dose levels.
Woodside Acquisitions Inc. recalled 34,240 Oral Rapid SARS-CoV-2 Antigen Test Kits distributed in Alabama and Georgia. The tests were distributed without FDA clearance or authorization for marketing.
Mesa Biotech is recalling approximately 6,162 units of the Accula SARS-CoV-2 Test due to an increased risk of false positive results, which could delay correct diagnosis and treatment.
The FDA is recalling 17,000 units of Joysbio SARS-CoV-2 Antigen Rapid Test Kits distributed in Alabama and Georgia. The tests were sold without FDA clearance or authorization for marketing in the United States.
Daavlin is recalling 1 Series CX phototherapy units due to a software bug that swaps calibration distance settings when resuming interrupted treatments, resulting in incorrect dosing.
Karl Storz Endoscopy is recalling Flexible Video-Uretero-Renoscope (FLEX-XC) models because they may fail to achieve adequate disinfection, creating potential microbial contamination risk.
Olympus is recalling 292 units of the BF-MP160F EVIS EXERA Bronchofibervideoscope due to updated instructions required for proper sterilization and reprocessing procedures. Updated guidance for chemical reprocessing, ETO gas sterilization, and disinfection rinsing steps is necessary.
Karl Storz Endoscopy is recalling Flexible Video-Uretero-Renoscope instruments due to inadequate microbial disinfection. All units manufactured since January 2018 are affected.
Microtek Medical Inc. is recalling TMJ Arthroscopy Drapes that contain latex but were mislabeled as latex-free, posing an allergic reaction risk to patients and healthcare workers with latex sensitivities.
Ethicon is recalling STRATAFIX surgical sutures (lots AAHM529 and AAHQ049) due to component mix-ups resulting in incorrect needle types, sizes, or suture lengths. 2,808 units distributed internationally are affected.
The FDA is recalling KARL STORZ Slim Nasopharyngolaryngoscope models 11001RD1 and 11001RDK1 because they fail to achieve adequate disinfection, potentially allowing microorganisms to persist on the device and transmit between patients.
Karl Storz Flexible Cystoscope units may not be properly disinfected because the disinfection process fails to achieve the expected reduction of microorganisms. All units manufactured since January 2018 are potentially affected.