Artegraft¿ Collagen Vascular Graft — Class II medical device recall Z-0289-2026
Ongoing recall by LeMaitre Vascular, Inc., reported 2025-10-29, distributed in AR. The device was incorrectly packed in the wrong size labeled outer packaging.
| Recall number | Z-0289-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | LeMaitre Vascular, Inc., North Brunswick, NJ, United States |
| Recall initiated | 2025-09-25 |
| Classified | 2025-10-23 |
| Reported by FDA | 2025-10-29 |
| Distributed | AR |
| Quantity | 1 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00316837000343 |
| Serial numbers | 23MM581-016 |
| Model numbers | AG1015 |
Product
Artegraft¿ Collagen Vascular Graft; REF: AG1015;
Reason for recall
The device was incorrectly packed in the wrong size labeled outer packaging.
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-0289-2026. 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.