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
O-Two Medical is recalling 119 e600 Automatic Transport Ventilators because a manufacturing defect may cause the unit to catch fire.
ICU Medical is recalling one lot of ChemoLock Vial Spike devices due to a potential for containing burr particulate. The recall covers 2,050 units distributed in the US and internationally.
Smiths Medical is recalling Portex 550 ml Sterile Water Humidifiers because leaking containers may compromise sterility, potentially exposing patients to infectious agents.
Smiths Medical is recalling Portex 1000 ml Sterile Water USP Pour Bottles because leaking containers may lack sterility assurance, posing a risk of exposure to infectious agents.
Terrific Care LLC is recalling CoaguChek XS PT Test Strips sold via MedEx Supply due to potential for abnormally high INR test results.
Smiths Medical is recalling Portex 350 ml Sterile Water Humidifiers because leaking containers may expose patients to infectious agents.
Medex Cardio-Pulmonary Inc. is recalling 54,924 Medline Prefilled 550 ml Sterile bags due to leaking containers that may compromise sterility.
Smiths Medical is recalling Portex 550 ml Sterile Water Humidifiers because leaking containers may compromise sterility, potentially exposing patients to infectious agents.
Edwards Lifesciences is recalling 9 units of Swan Ganz Thermodilution Catheters because incorrect lumen assembly causes reversed pressure readings.
Edwards Lifesciences is recalling 459 Swan Ganz Thermodilution Catheters because incorrect lumen assembly causes reversed pressure readings, potentially leading to misdiagnosis.
Draeger Medical is recalling 170 units of VentStar Basic 250 breathing circuits because they were incorrectly pre-assembled, creating a risk of incorrect connection or short circuiting.
Medtronic is recalling StealthStation Cranial and Synergy Cranial software due to an incorrect display of the Biopsy Depth Gauge that resulted in the biopsy of healthy tissue.
OriGen Biomedical is recalling 134 units of the VV19F Reinforced Dual Lumen Cannula because the extension tube may separate from the hub, posing a risk of blood loss.
Alcon is recalling the CyPass Micro-Stent implant because long-term study data showed statistically significant endothelial cell loss in patients who received the device.
Ventana Medical Systems is recalling 468 units of CINtec p16 Histology reagent because leaking dispensers may cause false negative test results.
Draeger Medical is recalling 72 Apollo Anesthesia Machines because a fault could allow the device to deliver a hypoxic gas mixture to patients, posing a risk of death.
Draeger Medical is recalling 62 Fabius GS Premium Anesthesia Machines because a fault could allow the device to deliver a hypoxic gas mixture to patients.
Draeger Medical is recalling four Fabius GS MRI Anesthesia Machines because a fault could allow the device to deliver a hypoxic gas mixture to patients, potentially causing death.
Draeger Medical is recalling 31 Fabius GS Tiro anesthesia machines because a fault could allow 100% nitrous oxide delivery, creating a risk of hypoxic mixtures and patient death.
Abbott is recalling HeartMate 3 LVAS Implant Kits due to reports of outflow graft twist occlusions that can cause serious adverse events.
Medtronic is recalling 951 Compia MRI CRT-Ds because a defect may prevent the delivery of high and low voltage therapy.
Medtronic is recalling 951 Evera ICDs and CRT-Ds because a defect may prevent the devices from delivering high or low voltage therapy.
Cook Medical is recalling Zenith Alpha Thoracic Endovascular Grafts due to reports of graft thrombosis and occlusion, including one patient death.
Maquet Datascope is recalling 12,319 CS 100 Intra-Aortic Balloon Pumps because electrical and autofill failures prevented the device from initiating therapy, which has been associated with a patient death.
Maquet Datascope is recalling 12,319 CS 100i Intra-Aortic Balloon Pumps because electrical failures prevented the device from initiating therapy, which has been associated with a patient death.