Cook Medical Incorporated recalls
10 recalls in our records from 2014 to 2025: 10 FDA medical devices.
Recalls with full detail pages
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Cook Medical Incorporated medical device recall: Zenith Alpha 2 Thoracic Endovascular Graft
Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
Earlier and other recalls
These link to the official agency notice.
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Cook Medical Incorporated medical device recall: EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle Official notice ↗
Devices may contain elevated levels of bacterial endotoxin.
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Cook Medical Llc medical device recall: MINC+ Benchtop Incubator Official notice ↗
The MINC+ device is susceptible to losing temperature control of electrostatic discharge (static electricity) is applied to the lid of the device. This may lead to…
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Cook Medical Incorporated medical device recall: Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog… Official notice ↗
IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
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Cook Medical Llc medical device recall: Disposable Humidification Flask Official notice ↗
A small percentage of the Disposable Humidification Flasks may have a manufacturing defect that can cause the silicone stoppers to dislodge or gas to leak from the…
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Cook Medical Incorporated medical device recall: Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Official notice ↗
Updates to the Instructions for Use.
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Cook Medical Incorporated medical device recall: Zilver 518 Biliary Stent 4mm x 20mm Official notice ↗
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…
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Cook Medical Incorporated medical device recall: Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic… Official notice ↗
There have been five reports of graft thrombosis/occlusion during global commercial use, each following treatment for BTAI. One case resulted in patient death, and three…
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Cook Medical Incorporated medical device recall: Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System Official notice ↗
Manufacturing of the joint between the inner catheter and stylet of the delivery system does not consistently meet specifications, and the joint may separate during…
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Cook Medical Incorporated medical device recall: Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle… Official notice ↗
MEDINVENTS, the manufacturer of the Spirotome" Soft-Tissue Biopsy Needle Set distributed by Cook Medical, has initiated a voluntary recall of these products. The…
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.