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
Mint Medical is recalling mint Lesion software versions 3.9.0–3.9.5 due to a malfunction that may display incorrect orientation labels for certain medical images. 65 units were distributed in the US and internationally.
CooperSurgical is recalling K-Systems G73 Dry Bath Incubators because warming surfaces may exceed the desired set temperature. The device alarms when this occurs.
Augustine Temperature Management recalled Hillrom Temperature Management Controllers (Models WC71, WC77, and MP 2083516) due to power-on self-test error code EA POST. No injuries or illnesses reported.
A defective power component in Noah Medical's Galaxy System bronchoscope may cause sudden power loss during procedures, potentially leading to lung injury or pneumotharax.
GE OEC 9800 fluoroscopic X-ray systems are recalled due to insufficient sealing of X-ray tubes, which can result in oil leaks and loss of imaging capability. 25 systems distributed in the U.S. and internationally are affected.
GE OEC Elite mobile fluoroscopic X-ray systems are recalled due to insufficient sealing of X-ray tubes, which can cause oil leaks and loss of imaging capability. Approximately 100 systems have been affected.
CooperSurgical recalls 37 K-Systems G85 Mini Incubators because the device warming surfaces may exceed the desired set temperature. The unit alarms when this occurs, but affected serial numbers require verification.
Medline is recalling the HUDSON RCI mBrace ET tube holder because defective adhesive and frame elements may cause pressure and skin injury to the face.
The K-Systems T47 Warming Plate has a temperature control defect where warming surfaces may exceed desired set temperatures. CooperSurgical is recalling 22 affected units distributed to fertility clinics.
Medline is recalling HUDSON RCI mBrace ET tube holders because defective adhesive and frame can cause pressure on patients' cheeks and lips, risking skin injury. The risk depends on device positioning.
Spectranetics is recalling the Turbo Elite Laser Atherectomy Catheter because the marker band can detach from the catheter tip and remain in the patient. This defect was identified through customer complaints.
Medline's HUDSON RCI mBrace ET tube holder is being recalled because its adhesive and frame design may put excessive pressure on patients' cheekbones and upper lip, potentially causing skin injury.
A software issue in the BD Pyxis CII Safe ES automated dispensing cabinet may cause it to open the wrong medication pocket, risking incorrect medication removal or refills.
DiaSorin Inc. is recalling over 21,900 LIAISON Q.S.E.T. Device Plus units worldwide due to loose caps that may leak buffer, potentially resulting in incorrect stool sample test results.
An automated medication dispensing cabinet may open the wrong storage pocket due to a software malfunction, potentially leading to incorrect medication removal. The manufacturer is recalling affected units.
Micro-X Ltd. is recalling five MICRO-X Rover Mobile X-ray Systems due to a timing defect that prevents adequate X-ray exposures. The 4 millisecond exposure time does not allow sufficient tolerance for diagnostic-quality imaging.
Hermes Medical Solutions is recalling Hybrid Recon software (versions 4.0.0x and 5.0.0) due to a potential software configuration issue that may cause incorrect alignment during SPECT/CT image reconstruction. The issue affects 778 systems in the U.S. and internationally.
Noah Medical is recalling Galaxy bronchoscope units due to risk that biopsy tools may require excessive force or fail to pass through the scope channel when the bronchoscope is sharply bent, potentially causing tissue injury or pneumothorax.
Micro-X Ltd. is recalling 18 MICRO-X Rover Mobile X-ray Systems because they can deliver lower radiation doses than operators set. The affected units use Control Board PCBA 12425-03 or earlier.
Cardinal Health is recalling 940,203 SMS Elastic Cuff Thumbhook Level 3 Isolation Gowns because the raw materials may fail hydrostatic pressure specifications, preventing them from meeting required AAMI Level 3 protection standards.
The BD Pyxis MedStation ES automated dispensing cabinet may dispense the wrong medication due to a software issue, potentially causing medication errors and inventory shortages.
Folsom Metal Products recalls 42 sets of DKS Disposable Kerrison System surgical instruments inadvertently distributed without commercial distribution approval. Four units were not sterilized.
Cardinal Health is recalling 940,203 Convertor Isolation Gowns because raw materials may prevent them from meeting AAMI Level 3 protection specifications.
Beckman Coulter recalls an Access Intact PTH assay used on the DxI 9000 analyzer because samples stored on the device may produce falsely low hormone-level results, potentially leading to missed diagnosis or delayed treatment.
Philips Allura Xper radiological systems may experience propeller motor and x-ray tube locking bolt breaks, causing erratic C-arm movements with potential for collision with patients or bystanders, and unnecessary radiation exposure.