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Z-0289-2026Class II

LeMaitre Vascular, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
LeMaitre Vascular, Inc.
Product type
Device
Status
Ongoing
Report date
2025-10-29
Distribution
US distribution to the state of: AR
Firm state
NJ
Product quantity
1 unit
Initiated by
Voluntary: Firm initiated
Reason for recall

The device was incorrectly packed in the wrong size labeled outer packaging.

Product description

Artegraft¿ Collagen Vascular Graft; REF: AG1015;

Code / lot info

REF: AG1015; UDI-DI: 00316837000343; Lot/Serial Number: 23MM581-016;

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →