Artegraft Vascular Graft; REF#: AG740;
FDA Recall Z-1574-2026 · Posted 2026-03-19
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Recalling FirmLeMaitre Vascular, Inc.
Recall StatusOpen, Classified
Product CodeLXA
Date Initiated2026-02-10
Product Quantity1 unit
Reason for Recall
Labeling mix-up resulting in the incorrect lot outer packaging of product.
Firm Action
On February 10, 2026 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken:
1. Check your inventory against the list of lots in this letter. Immediately quarantine any
recalled devices.
2. Complete the form at the end of this letter. Please note that you must return the form
even if you have no devices in inventory.
3. If the product has been implanted, graft explantation/patient intervention is NOT
required.
4. Scan the reply form and send it to [email protected].
5. When a recalled device has been returned to LeMaitre Vascular, a replacement device will be provided.
6. If you have transferred devices to another facility, please forward a copy of this recall letter to them.
If you have any questions, contact Monte Nelson; [email protected]; 732-422-8333
Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time, or email [email protected]
Root Cause
Labeling Change Control
Distribution Pattern
US Nationwide distribution in the state of IL.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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