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Cook Medical Incorporated Recalls
53 recalls on record · November 5, 2014 to October 22, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
October 22, 2025Medical DevicesFDA
Cook Medical Incorporated recalls Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-1
Hazard: Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
May 22, 2024Medical DevicesFDA
Cook Medical Incorporated recalls EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520
Hazard: Devices may contain elevated levels of bacterial endotoxin.
May 22, 2024Medical DevicesFDA
Cook Medical Incorporated recalls EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
Hazard: Devices may contain elevated levels of bacterial endotoxin.
April 13, 2022Medical DevicesFDA
Cook Medical Incorporated recalls Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT G34502; IGTCFS-65-1-JUG-CELEC
Hazard: IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
April 13, 2022Medical DevicesFDA
Cook Medical Incorporated recalls Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTC
Hazard: IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
March 27, 2019Medical DevicesFDA
Cook Medical Incorporated recalls Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-C ELECT
Hazard: Updates to the Instructions for Use.
March 27, 2019Medical DevicesFDA
Cook Medical Incorporated recalls Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Catalog Number GTCFS-65-1-JUG-CELECT-PT Product
Hazard: Updates to the Instructions for Use.
March 27, 2019Medical DevicesFDA
Cook Medical Incorporated recalls Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-CELECT-PT Produc
Hazard: Updates to the Instructions for Use.
March 27, 2019Medical DevicesFDA
Cook Medical Incorporated recalls Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-TULIP Produ
Hazard: Updates to the Instructions for Use.
March 27, 2019Medical DevicesFDA
Cook Medical Incorporated recalls Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Catalog Number IGTCFS-65-1-JUG-TULIP Product Usage: T
Hazard: Updates to the Instructions for Use.
March 27, 2019Medical DevicesFDA
Cook Medical Incorporated recalls Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-TU LIP Product Usage:
Hazard: Updates to the Instructions for Use.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 635 Biliary Stent 14mm x 80mm, Catalog Number: ZIB6-125-14.0-80 Product Usage: The Zilver 518 and 635 Bilia
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver Biliary 518 Stent 5mm x 60mm, Catalog Number: ZIB5-125-5.0-60 Product Usage: The Zilver 518 and 635 Biliar
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-80-5.0-80 Product Usage: The Zilver 518 and 635 Biliary
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-80-5.0-60 Product Usage: The Zilver 518 and 635 Biliary
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 635 Biliary Stent 5mm x 40mm, Catalog Number: ZIB6-80-5.0-40 Product Usage: The Zilver 518 and 635 Biliary
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-80-5.0-30 Product Usage: The Zilver 518 and 635 Biliary
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 635 Biliary Stent 5mm x 20mm, Catalog Number: ZIB6-80-5.0-20 Product Usage: The Zilver 518 and 635 Biliary
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-80-4.0-80 Product Usage: The Zilver 518 and 635 Biliary
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 635 Biliary Stent 14mm x 80mm, Catalog Number: ZIB6-80-14.0-80 Product Usage: The Zilver 518 and 635 Biliar
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-80-14.0-60 Product Usage: The Zilver 518 and 635 Biliar
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-80-14.0-40 Product Usage: The Zilver 518 and 635 Biliar
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-80-14.0-30 Product Usage: The Zilver 518 and 635 Biliar
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-80-12.0-80 Product Usage: The Zilver 518 and 635 Biliar
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-80-12.0-60 Product Usage: The Zilver 518 and 635 Biliar
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-80-12.0-40 Product Usage: The Zilver 518 and 635 Biliar
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-80-12.0-30 Product Usage: The Zilver 518 and 635 Biliar
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-125-5.0-80 Product Usage: The Zilver 518 and 635 Biliary
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-125-5.0-60 Product Usage: The Zilver 518 and 635 Biliary
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
November 7, 2018Medical DevicesFDA
Cook Medical Incorporated recalls Zilver 635 Biliary Stent 5mm x 40mm, Catalog Number: ZIB6-125-5.0-40 Product Usage: The Zilver 518 and 635 Biliary
Hazard: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.