Zenith Alpha 2 Thoracic Endovascular Graft — Class I medical device recall Z-0043-2026
Ongoing recall by Cook Medical Incorporated, reported 2025-10-22, distributed in AL, AR, AZ, CA, CT, DC, DE, FL…. Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, pot
| Recall number | Z-0043-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Medical Incorporated, Bloomington, IN, United States |
| Recall initiated | 2025-09-18 |
| Classified | 2025-10-10 |
| Reported by FDA | 2025-10-22 |
| Distributed | 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 |
| Countries outside the US | CH, DE, IT, PL, SE |
| Quantity | 695 |
| UPC / GTIN / UDI-DI | 00827002599079, 00827002599109, 00827002599123, 00827002599154, 00827002599208, 00827002599215, 00827002599239, 00827002599253, 00827002599260, 00827002599314, 00827002599321, 00827002599345, 00827002599352, 00827002599376, 00827002599383, 00827002599437, 00827002599444, 00827002599468, 00827002599475, 00827002599499, 00827002599505, 00827002600638, 00827002600645, 00827002600669, 00827002600676 and 47 more |
| Lot numbers | E4626917, E4627437, E4627438, E4627439, E4627440, E4627442, E4627443, E4627444, E4627445, E4627446, E4627447, E4627448, E4627449, E4627450, E4627451, E4627452, E4627453, E4627454, E4627455, E4627456, E4627457, E4627458, E4627459, E4627460, E4628827, E4628828, E4628829, E4628830, E4628831, E4628832, E4628833, E4628834, E4628835, E4628836, E4628837, E4628838, E4628839, E4628841, E4628842, E4628843 and 460 more |
| Model numbers | ZTA2-P-40-117, ZTA2-P-40-117-W, ZTA2-P-40-142, ZTA2-P-40-142-W, ZTA2-P-40-167, ZTA2-P-40-167-DEMO, ZTA2-P-40-167-W, ZTA2-P-40-217, 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-44-152, ZTA2-P-44-152-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 and 20 more |
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
Reason for recall
Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0043-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.