Artegraft¿ Collagen Vascular Graft; REF: AG1015;
FDA Recall #Z-0289-2026 — Class II — September 25, 2025
Product Description
Artegraft¿ Collagen Vascular Graft; REF: AG1015;
Reason for Recall
The device was incorrectly packed in the wrong size labeled outer packaging.
Recalling Firm
LeMaitre Vascular, Inc. — North Brunswick, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1 unit
Distribution
US distribution to the state of: AR
Code Information
REF: AG1015; UDI-DI: 00316837000343; Lot/Serial Number: 23MM581-016;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated