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
Servo-u MR Ventilator System (Model 6888800) may measure patient circuit compliance inaccurately due to incorrect pre-use leakage testing and incorrect active humidifier use.
The Servo-u Ventilator System is being recalled because patient circuit compliance may be measured inaccurately during the patient circuit test. 874 units are affected.
Philips Respironics is recalling BiPAP A30 and BiPAP Hybrid A30 ventilators. The devices do not have an indication for use in patients with respiratory failure.
Integra LifeSciences is recalling Extended Tip Applicators (15 CM, Box of 5) because they may contain out-of-specification levels of endotoxins and lack sterility assurance.
Insulet Corporation is recalling the Omnipod 5 iOS App due to a software issue where decimal separators are not recognized in manual insulin entry, potentially causing insulin overdose and severe hypoglycemia.
SunMed Holdings is recalling Broselow Pediatric Emergency Rainbow Tape due to incorrect values printed on the tape that could lead to improper medication dosing and defibrillation in pediatric emergency care.
Becton Dickinson is recalling BD BACTEC MGIT 960 PZA Kit due to reports of intermittent false resistance results during pyrazinamide susceptibility testing of Mycobacterium tuberculosis. The issue affects units distributed worldwide.
Integra LifeSciences is recalling Extended Tip Applicator 8CM devices due to potentially out-of-specification endotoxin levels and lack of sterility assurance. The recall affects 6,216 units distributed across the US and internationally.
Integra LifeSciences Corp. is recalling the MicroMyst Applicator Box of 5 due to lack of sterility assurance. The product is used with the Integra Flow Source for controlled application of two liquids.
Integra LifeSciences is recalling Extended Tip Applicator 8CM devices nationwide and internationally because they may contain potentially out-of-specification endotoxin levels and lack sterility assurance.
Dexcom, Inc. is recalling 26,291 units of the Dexcom One+ Continuous Glucose Monitoring System due to defective foam or assembly errors that may prevent audible alerts for low or high blood glucose levels, potentially leading to seizures, loss of consciousness, or death.
Dexcom, Inc. is recalling Dexcom One Continuous Glucose Monitoring System receivers due to potential defective foam or assembly errors that may cause the speaker to lose contact with internal components, resulting in missed audible alerts for dangerous blood glucose levels.
Dexcom, Inc. is recalling Dexcom G7 Glucose Receiver units due to defective foam or assembly error that may cause the speaker to lose contact with the circuit board, preventing audible alerts for low or high blood glucose.
Cook Incorporated is recalling specific lots of Beacon Tip 5.0 Fr Angiographic catheters due to the risk that the catheter tip may separate during use. The affected catheters were distributed worldwide.
Dexcom G6 Glucose Receiver units may have defective foam or assembly errors that disable audible alerts for dangerously low or high blood glucose, risking seizures, loss of consciousness, or death.
Tecfen Medical is recalling 2.8mm Slit Knife, Angled (Model QKN2808) ophthalmic surgical instruments due to sterility assurance concerns. Affected units were distributed in the US and internationally.
Covidien is recalling Newport HT70 and HT70Plus ventilators due to capacitor failures that may cause the device to shut down unexpectedly or fail to alarm, risking respiratory failure and oxygen deprivation in patients.
Zyno Medical LLC is recalling the Z-800F Infusion System because unreleased software versions were installed on distributed devices without verification or validation. This poses a risk to patients receiving intravenous infusion therapy.
Zyno Medical LLC is recalling 613 units of the Z-800 Infusion System distributed nationwide because unreleased software versions were installed on the devices without verification or validation.
Medtronic Azure S DR MRI SureScan pacemakers may experience sudden battery power failure without warning, potentially interrupting therapy and leading to cardiac arrest or hospitalization. Affected devices are being recalled internationally.
BD Texium closed system drug transfer devices in multiple sizes may leak at the interface between the male luer component and needle-free connector, potentially causing treatment delays, exposure to hazardous drugs, and underdosing.
Zyno Medical LLC is recalling the Z-800W Infusion System because unreleased software versions were installed on devices without verification or validation.
Fresenius Kabi USA is recalling IVENIX INFUSION SYSTEM LVP Blood Products Administration Sets due to a mis-assembly error that may prevent the drip chamber filter from properly filtering large blood particulates.
Philips is recalling one Intera 1.5T Explorer/Nova Dual MRI system due to a gradient coil component that may overheat, produce smoke, or ignite, risking patient and operator injury.
Philips Medical Systems has recalled Azurion R1.x and R2.x X-ray systems worldwide due to a software issue that can cause loss of imaging functionality and delay treatment, potentially resulting in serious harm or death in patients undergoing urgent or complex interventions.