Cook Medical Incorporated

FDA Regulatory Profile

Summary

Total Recalls
53 (2 Class I)
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0043-2026Class IZenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-4September 18, 2025
Z-1833-2024Class IIEchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520April 1, 2024
Z-1832-2024Class IIEchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012April 1, 2024
Z-0875-2022Class IIIGunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-February 14, 2022
Z-0876-2022Class IIICook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT G34502; IFebruary 14, 2022
Z-1025-2019Class IIICook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Catalog Number GTCFS-65-1-JUG-February 25, 2019
Z-1021-2019Class IIIGunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-TU LIPFebruary 25, 2019
Z-1024-2019Class IIICook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEMFebruary 25, 2019
Z-1023-2019Class IIIGunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-February 25, 2019
Z-1022-2019Class IIIGunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Catalog Number IGTCFS-65-1-JUG-TULIP February 25, 2019
Z-1026-2019Class IIICook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTFebruary 25, 2019
Z-0341-2019Class IIZilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-80-14.0-30 Product Usage: The ZilveSeptember 25, 2018
Z-0347-2019Class IIZilver 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-80-5.0-30 Product Usage: The Zilver September 25, 2018
Z-0340-2019Class IIZilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-80-12.0-80 Product Usage: The ZilveSeptember 25, 2018
Z-0334-2019Class IIZilver 635 Biliary Stent 5mm x 40mm, Catalog Number: ZIB6-125-5.0-40 Product Usage: The ZilverSeptember 25, 2018
Z-0333-2019Class IIZilver 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-125-5.0-30 Product Usage: The ZilverSeptember 25, 2018
Z-0324-2019Class IIZilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-125-12.0-30 Product Usage: The ZilvSeptember 25, 2018
Z-0327-2019Class IIZilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-125-12.0-80 Product Usage: The ZilvSeptember 25, 2018
Z-0336-2019Class IIZilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-125-5.0-80 Product Usage: The ZilverSeptember 25, 2018
Z-0332-2019Class IIZilver 635 Biliary Stent 5mm x 20mm, Catalog Number: ZIB6-125-5.0-20 Product Usage: The ZilverSeptember 25, 2018