Stop using now Medical device recall · FDA · Published September 18, 2025

Cook Medical recalls Zenith Alpha 2 Thoracic Grafts with PTFE coating scrapings risk

Cook Medical recalls Zenith Alpha 2 Thoracic Endovascular Grafts (ZTA2- prefix) due to potential PTFE coating scrapings that could cause intravascular embolization during deployment.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0043-2026Medical device Cook Medical ›

Stop using this now

Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.

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Contact the company

Recalling firmCook Medical Incorporated400 N Daniels Way · Bloomington, IN 47404-9155

✎ GovInfoNow plain-language explainer

Cook Medical is recalling certain Zenith Alpha 2 Thoracic Endovascular Grafts because they may contain PTFE coating scrapings that could be released during deployment, potentially causing intravascular embolization. This is a serious medical risk that requires immediate attention. Read more at govinfonow.com/recall/51260-cook-medical-recalls-zenith-alpha-2-thoracic-grafts-with-ptfe.

Source Summary by GovInfoNow · govinfonow.com/recall/51260-cook-medical-recalls-zenith-alpha-2-thoracic-grafts-with-ptfe · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0043-2026

Cite this page

“Cook Medical recalls Zenith Alpha 2 Thoracic Grafts with PTFE coating scrapings risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51260-cook-medical-recalls-zenith-alpha-2-thoracic-grafts-with-ptfe. Based on FDA recall #Z-0043-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0043-2026%22&limit=1).

The FDA announced on Sept. 18, 2025, that Cook Medical Incorporated is recalling the Zenith Alpha 2 Thoracic Endovascular Graft because affected devices may contain PTFE coating scrapings. The agency said these scrapings could be released during deployment, potentially causing intravascular embolization.

How to tell if you have it

Brand: Cook Medical
Product: Zenith Alpha 2 Thoracic Endovascular Graft
Catalog Prefix: ZTA2-
Reference Part Numbers: ZTA2-P-40-117-W, ZTA2-P-40-167, ZTA2-P-40-167-W, ZTA2-P-40-217-W, ZTA2-P-42-121, ZTA2-P-42-121-W, ZTA2-P-42-173, ZTA2-P-42-173-W, ZTA2-P-42-225, ZTA2-P-42-225-W, ZTA2-P-44-125, ZTA2-P-44-125-W, ZTA2-P-44-179, ZTA2-P-44-179-W, ZTA2-P-44-233, ZTA2-P-44-233-W, ZTA2-P-46-125, ZTA2-P-46-125-W, ZTA2-P-46-179, ZTA2-P-46-179-W, ZTA2-P-46-233-W, ZTA2-PT-40-36-167, ZTA2-PT-40-36-167-W, ZTA2-PT-40-36-217, ZTA2-PT-40-36-217-W, ZTA2-PT-42-38-173, ZTA2-PT-42-38-173-W, ZTA2-PT-42-38-225, ZTA2-PT-42-38-225-W, ZTA2-PT-44-40-179, ZTA2-PT-44-40-179-W, ZTA2-PT-44-40-233-W, ZTA2-PT-46-42-179, ZTA2-PT-46-42-179-W, ZTA2-PT-46-42-233, ZTA2-PT-46-42-233-W, ZTA2-P-46-233, ZTA2-PT-44-40-233, ZTA2-P-40-217, ZTA2-P-40-117, ZTA2-P-40-167-DEMO, ZTA2-P-44-152-W, ZTA2-P-40-142, ZTA2-P-44-152, ZTA2-P-40-142-W
Units affected: 695

The hazard

According to the FDA, affected devices may contain PTFE coating scrapings. The agency said these scrapings could be released during device deployment, potentially causing intravascular embolization.

Context

GovInfoNow's records show Cook Medical Incorporated has four other recalls on record since Sept. 25, 2018. Other recent recalls of similar products include the Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (March 3, 2026), the Cook Ring Transjugular Intrahepatic Access Sets Recall (Nov. 26, 2025), and the St. Jude Medical Reprocessed Catheters Recall (Dec. 22, 2025).

How to tell if you have this one

Check for the product name 'Zenith Alpha 2 Thoracic Endovascular Graft' with Catalog Prefix ZTA2- and Reference Part Numbers listed in the recall. The specific part numbers and lots are detailed in the official recall notice.

Brand
Cook Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop using it now
Immediately discontinue use of the recalled Zenith Alpha 2 Thoracic Endovascular Grafts if you have them.

Where it went and when

Where it was distributed

Distributed in 30 states and D.C., and outside the U.S.

FDA distribution: “Domestic distribution to AL AR AZ CA CT DC DE FL GA IL IN LA MA MD MI MN MO NC NJ NY OH OR PA SC TN TX UT VA WA WI WV International distribution to Switzerland, Germany, Italy, Poland, and Sweden” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Connecticut, Delaware, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 34 days after the firm started it.

Sep 18, 2025Firm started the recall
Oct 10, 2025FDA classified it Class I
Oct 22, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/51260-cook-medical-recalls-zenith-alpha-2-thoracic-grafts-with-ptfe">Cook Medical recalls Zenith Alpha 2 Thoracic Grafts with PTFE coating scrapings risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0043-2026 (September 18, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0043-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.