FDA Device recall Z-0289-2026
Artegraft¿ Collagen Vascular Graft
- FDA Device
- Class II
- ongoing
- Published 2025-10-29
On 2025-10-29 the FDA classified a Class II recall of Artegraft¿ Collagen Vascular Graft by Lemaitre Vascular, citing the device was incorrectly packed in the wrong size labeled outer packaging.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0289-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-25 |
| Published | 2025-10-29 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Lemaitre Vascular |
| Distribution | AR |
Product
Artegraft¿ Collagen Vascular Graft; REF: AG1015;
Reason
The device was incorrectly packed in the wrong size labeled outer packaging.
Identifiers
| code_info | REF: AG1015; UDI-DI: 00316837000343; Lot/Serial Number: 23MM581-016; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0289-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.