Recall archive
8 recalls · page 1 of 1
Reported Oct 22, 2025
Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cook Medical Incorporated
Matched: Brand — Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular…
FDA (openFDA device enforcement)
Reported May 22, 2024
EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Medical Incorporated
Matched: Brand — Devices may contain elevated levels of bacterial endotoxin.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 13, 2022
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917;…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Cook Medical Incorporated
Matched: Brand — IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 27, 2019
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-TU LIP Product Usage: The…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Cook Medical Incorporated
Matched: Brand — Updates to the Instructions for Use.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 7, 2018
Zilver 518 Biliary Stent 4mm x 20mm, Catalog Number: ZIB5-125-4.0-20 Product Usage: The Zilver 518 and 635 Biliary…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Medical Incorporated
Matched: Brand — 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…
38 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 16, 2017
Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cook Medical Incorporated
Matched: Brand — There have been five reports of graft thrombosis/occlusion during global commercial use, each following treatment for BTAI. One case resulted in…
FDA (openFDA device enforcement)
Reported Feb 3, 2016
Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Medical Incorporated
Matched: Brand — Manufacturing of the joint between the inner catheter and stylet of the delivery system does not consistently meet specifications, and the joint may…
FDA (openFDA device enforcement)
Reported Nov 5, 2014
Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set includes a two-part introducer needle that…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Medical Incorporated
Matched: Brand · Reason for recall — MEDINVENTS, the manufacturer of the Spirotome" Soft-Tissue Biopsy Needle Set distributed by Cook Medical, has initiated a voluntary recall of these…
FDA (openFDA device enforcement)
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