Use cautionMedical device recall · FDA · Published August 11, 2020
Cook Zenith Alpha Abdominal Endovascular Graft Recall: Excess glue in handle may prevent
Cook Inc. recalls Zenith Alpha Abdominal Endovascular Grafts with excess glue in the handle that may prevent proper deployment. Affected units have specific reference part numbers and lot numbers listed in the recall notice.
May contain excess glue within the handle of the delivery system, resulting in an inability to fully deploy the graft via the standard method or troubleshooting deployment method provided in the IFU
Take action
Contact the company
📍Recalling firmCook Inc.750 N Daniels Way · Bloomington, IN 47404-9120
“Cook Zenith Alpha Abdominal Endovascular Graft Recall: Excess glue in handle may prevent.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64504-cook-zenith-alpha-abdominal-endovascular-graft-recall-excess-glue-in. Based on FDA recall #Z-2964-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2964-2020%22&limit=1).
Cook Inc. recalled the Zenith Alpha Abdominal Endovascular Graft on Aug. 11, 2020, because excess glue in the delivery system handle may prevent full deployment, according to the FDA. The agency announced the Class II recall of 684 units distributed only outside the United States.
Lot Codes: See record for specific lot numbers associated with each RPN
Quantity: 684 units
Distribution: Foreign Only (Canada, Sweden, Austria, Belgium, Czech Republic, Denmark, España, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italia, Nederland, Norway, Poland, Portugal, Reunion, Serbia, Slovenia, South Africa, United Arab Emirates, United Kingdom, Australia, Hong Kong, Japan, New Caledonia, New Zealand, Thailand)
The hazard
The grafts may contain excess glue within the handle of the delivery system. This defect can result in an inability to fully deploy the graft via the standard method or troubleshooting deployment method provided in the Instructions for Use (IFU).
Context
GovInfoNow's records show Cook Inc. has issued 38 other recalls since July 31, 2017. Other recent recalls of similar products include the Cook Flexor Check-Flo Introducer Ansel Modification recall (Nov. 12, 2021) and the Cook Skinny Needle with Chiba Tip Recall (Oct. 13, 2021). Additional context includes the Cook Ring Transjugular Intrahepatic Access Sets Recall (Nov. 26, 2025), the Merit Medical Allwell Angioplasty Pack Recall (Dec. 4, 2025), and the Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (March 3, 2026).
How to tell if you have this one
Check the reference part numbers (RPN) listed: ZIMB-22-108 through ZIMB-36-98. Also check the lot numbers provided for each part number in the recall notice.
Brand
Cook Inc.
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Manufacturer
Reach out to Cook Inc. to confirm if your specific model and lot number is affected and to get instructions for replacement or repair.
How this recall unfolded
Recall timeline
FDA terminated this recall 12 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-2964-2020 (August 11, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2964-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.