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Cook Medical Incorporated FDA Recalls
5 recalls on file across devices, 1 of them Class I and 3 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-1Class ISep 18, 2025Affected devices may contain PTFE coating scrapings. Scrapin |
| EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012Class IIApr 1, 2024Devices may contain elevated levels of bacterial endotoxin. |
| EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520Class IIApr 1, 2024Devices may contain elevated levels of bacterial endotoxin. |
| Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT G34502; IGTCFS-65-1-JUG-CELECClass IIIFeb 14, 2022IFU update includes an update to the Device description, In |
| Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCClass IIIFeb 14, 2022IFU update includes an update to the Device description, In |