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U.S. Department of Health and Human Services

Class 2 Device Recall Artegraft Vascular Graft

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 Class 2 Device Recall Artegraft Vascular Graftsee related information
Date Initiated by FirmFebruary 10, 2026
Date PostedMarch 19, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1574-2026
Recall Event ID 98409
Product Classification Tissue graft of 6mm and greater - Product Code LXA
ProductArtegraft Vascular Graft; REF#: AG740;
Code Information REF#: AG740; UDI-DI: 00316837000299; Serial Number: 24GG298-022; Expiration Date: 28Jun2027;
FEI Number 1000121696
Recalling Firm/
Manufacturer		 LeMaitre Vascular, Inc.
206 N Center Dr
North Brunswick NJ 08902-4246
For Additional Information ContactLaurie Churchill
781-704-1855
Manufacturer Reason
for Recall		Labeling mix-up resulting in the incorrect lot outer packaging of product.
FDA Determined
Cause 2		Labeling Change Control
ActionOn 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 recalls@lemaitre.com. 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; mnelson@lemaitre.com; 732-422-8333 Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time, or email Recalls@lemaitre.com
Quantity in Commerce1 unit
DistributionUS Nationwide distribution in the state of IL.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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