FDAClass IIOctober 29, 2025

Artegraft¿ Collagen Vascular Graft recall

Artegraft¿ Collagen Vascular Graft; REF: AG1015;

Why was Artegraft¿ Collagen Vascular Graft recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Artegraft¿ Collagen Vascular Graft; REF: AG1015;
Recalling firm
LeMaitre Vascular, Inc.
Quantity
1 unit
Distribution
US distribution to the state of: AR
Recall date
October 29, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls