Artegraft Collagen Vascular Graft (LeMaitre) – incorrect packaging (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Artegraft Collagen Vascular Graft; REF: AG1015;
Brand
LeMaitre Vascular, Inc.
Lot Codes / Batch Numbers
REF: AG1015, UDI-DI: 00316837000343, Lot/Serial Number: 23MM581-016
Products Sold
REF: AG1015; UDI-DI: 00316837000343; Lot/Serial Number: 23MM581-016;
LeMaitre Vascular, Inc. is recalling Artegraft Collagen Vascular Graft; REF: AG1015; due to The device was incorrectly packed in the wrong size labeled outer packaging.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The device was incorrectly packed in the wrong size labeled outer packaging.
Recommended Action
Per FDA guidance
On September 25, 2025, an "URGENT: MEDICAL DEVICE RECALL" letter was sent to the customer. Actions to be taken: Check your inventory against the list of lots in this letter. Immediately quarantine any recalled devices. Complete and return the form provided even if you have no devices in inventory. If the product has been implanted, graft explantation/patient intervention is NOT required. Scan the reply form and send it to recalls@lemaitre.com. When a recalled device has been returned to LeMaitre Vascular, a replacement device will be provided. If you have transferred devices to another facility, please forward a copy of this recall letter to them. If you have any questions, contact Sr. Director, Quality Affairs, via email: mnelson@lemaitre.com or at 732-422-8333 Monday through Friday, 8:00AM to 4:30 PM, Eastern Time.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AR
Page updated: Jan 10, 2026