Artegraft Collagen Vascular Graft — Class II medical device recall Z-0072-2026
Ongoing recall by LeMaitre Vascular, Inc., reported 2025-10-15. Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient im
| Recall number | Z-0072-2026 |
|---|---|
| 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 | 2025-08-25 |
| Classified | 2025-10-08 |
| Reported by FDA | 2025-10-15 |
| Countries outside the US | CH |
| Quantity | 10 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00316837000015, 00316837000022, 00316837000060, 00316837000084, 00316837000138 |
| Lot numbers | 24H361-022, AG630M, AG636M, AG730M, AG740M, AG845M |
| Model numbers | AG630M, AG636M, AG730M, AG740M, AG845M |
| Expiration dates | 2027-07-28 |
Product
Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve as a substitute conduit for blood where bypass or replacement of occluded or diseased arterial segments is required or to establish a conduit for hemodialysis.
Reason for recall
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
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-0072-2026. 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.