Class II — Cook Inc.
| Recalling firm | COOK, INC. |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Identified products may contain a damaged bushing within the delivery system, which could potentially result in difficulty or an inability to fully deploy the graft via the standard method provided in the IFU. |
| Product | Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair. |
| Quantity | 571 |
| Distribution | Foreign distribution to the countries of Canada, Chile, Argentina, Colombia, Great Britain, AUSTRIA Belgium. CZECH REPUBLIC DENMARK ESPAA France GERMANY GREECE HUNGARY ICELAND IRELAND ISRAEL Italia MARTINIQUE Nederland NORWAY POLAND PORTUGAL SERBIA SOUTH AFRICA SWEDEN UNITED KINGDOM Australia Hong Kong Thailand |
| Initiated | 2020-06-02 |
| Classified | 2020-07-09 |
| Terminated | 2022-05-05 |
| Recall number | Z-2546-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cook Inc. (Z-2546-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85805/
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