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
Brainlab's Origin Data Management software versions 3.1.0 through 3.2.1 may automatically merge patient records from unrelated individuals without user notification, creating a risk of incorrect patient data being used in clinical care.
American Contract Systems Inc is recalling CYSTO PACK cystoscopy kits because the company cannot confirm sterilization assurance requirements were met. Possible loss of functionality could delay or prolong patient treatment.
B. Braun Medical is recalling Introcan Safety 3 IV catheters because the valve housing may detach, causing fluid leakage. Approximately 28,200 units are affected.
American Contract Systems unable to confirm sterilization of 956 General Angio Pack kits distributed nationwide. Unsterile devices may lose functionality and delay patient treatment.
Medline Industries is recalling 114 units of Proxima Drape surgical drapes due to a potential breach in pouch packaging that could compromise sterility. Affected units were distributed nationwide.
Immuno-Mycologics' Candida ID Antigen may have reduced sensitivity, causing false negative diagnostic results. Lot F4171005 has been distributed worldwide including CA and OK.
Oridion Medical's CO2 sampling and airway adapter devices may be difficult to disconnect from endotracheal tubes, potentially causing treatment delays and serious respiratory complications in neonatal, infant, and pediatric patients.
American Contract Systems Inc is recalling 237 laparoscopy surgical packs because sterilization assurance could not be confirmed. The packs may experience loss of functionality and require treatment delays.
American Contract Systems cannot confirm Major Vascular Pack surgical kits were properly sterilized. Sterilization assurance failure could result in loss of functionality and delayed patient treatment.
American Contract Systems is recalling PICC line catheters because sterilization assurance requirements could not be confirmed. Unsterilized devices may lose functionality and delay patient treatment.
American Contract Systems Inc is recalling 534 kits of General Laparoscopic Pack-LF surgical instruments because sterilization assurance could not be confirmed. This could result in loss of functionality and treatment delays.
American Contract Systems Inc is recalling 1,200 DR DIULUS Injection Pack kits because the manufacturer cannot confirm sterilization assurance requirements were met. This may result in loss of functionality and treatment delays.
Merge Healthcare recalls Merge Cardio cardiovascular software due to measurement data inconsistency. When users manually edit or remeasure values in certain workflows, derived measurements may not match original measurements in patient reports.
The VERICIS Merge Cardio system may display inconsistent cardiovascular measurements in patient reports when specific workflows are used. This could affect clinical decisions based on the reported data.
American Contract Systems Inc is recalling 144 CYSTO Model SACY80R kits due to inability to confirm sterilization requirements were met. Unsterilized devices may lose functionality and delay patient treatment.
37 units of a modular stem orthopedic implant (Product Code 880-601/11) have been recalled due to an incorrect GTIN product identifier on the carton label, which belongs to a different product. No illnesses or injuries have been reported.
Beckman Coulter is recalling Access 2 Immunoassay Analyzers due to sample motor misalignment that may delay patient test result reporting. The recall affects 873 units distributed worldwide.
Waldemar Link is recalling 20 units of Modular Stem orthopedic implants due to incorrect GTIN labeling on the outer carton. The label bears a barcode for a different product.
Angiodynamics is recalling 1,800 units of IsoLoc prostate treatment balloons due to incorrect fill volume labeling. The affected devices were distributed nationwide.
A modular hip prosthetic stem (52 units) is being recalled due to an incorrect GTIN barcode on the outer carton label, which displays the code for a different product. No injuries have been reported.
Microbiologics Inc is recalling Helix Elite Inactivated SARS-CoV-2 quality control material (Lot HE0065-29) because the A549 human cell target may produce late Ct values, potentially affecting test result validity.
Beckman Coulter recalls certain DxI 9000 immunoassay analyzers due to firmware issues that can cause communication failures, potentially delaying patient result reporting.
Portex Endotracheal Tubes from Smiths Medical ASD, Inc. may have a smaller diameter than expected, potentially causing inadequate ventilation and patient hypoxia.
BD Care Coordination Engine infusion software may send outdated automated programming requests to care units. Healthcare facilities in affected US states should review their systems.
Medtronic is recalling 316,205 aortic root cannulas due to unexpected loose material in the male luer connector. If not identified before use, this defect could cause stroke; if identified, it may delay surgery.