Artegraft Collagen Vascular Grafts Model Numbers: — Class II medical device recall Z-0034-2026
Ongoing recall by LeMaitre Vascular, Inc., reported 2025-10-08, distributed nationwide. The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw mate
| Recall number | Z-0034-2026 |
|---|---|
| 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 | 2025-09-02 |
| Classified | 2025-10-02 |
| Reported by FDA | 2025-10-08 |
| Distributed | Nationwide (US) |
| Quantity | 28 units |
| UPC / GTIN / UDI-DI | 00316837000213, 00316837000220, 00316837000237, 00316837000244, 00316837000251, 00316837000268, 00316837000275, 00316837000282, 00316837000299, 00316837000305, 00316837000312, 00316837000329, 00316837000343, 00316837000350, 00316837000367 |
| Serial numbers | 23DD203-004, 23DD203-011, 23DD203-017, 23DD203-018, 23DD203-019, 23DD203-021, 23DD203-022, 23DD203-023, 23DD203-024, 23DD203-026, 23DD203-027, 23DD203-029, 23DD203-030, 23DD203-031, 23DD203-032, 23DD203-033, 23DD203-034, 23DD203-035, 23DD203-036, 23DD203-037, 23DD203-038, 23DD203-039, 23DD203-040, 23DD203-043, 23DD203-044 and 3 more |
| Model numbers | 00316837000213, 00316837000220, 00316837000237, 00316837000244, 00316837000251, 00316837000268, 00316837000275, 00316837000282, 00316837000299, 00316837000305, 00316837000312, 00316837000329, 00316837000343, 00316837000350, 00316837000367, 1015, 1030, 616, 630, 636, 640, 645, 715, 730, 735 and 5 more |
Product
Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;
Reason for recall
The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.
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-0034-2026. 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.