FDA Medical Device Recalls (openFDA)
LeMaitre Vascular, Inc.: Artegraft Vascular Graft; REF#: AG740;
- Recall number
- Z-1574-2026
- Recalling firm
- LeMaitre Vascular, Inc.
- Product
- Artegraft Vascular Graft; REF#: AG740;
- Status
- Open, Classified
- Initiated
- 2026-02-10
- Posted
- 2026-03-19
- Terminated
- not on file
- Reason
- Labeling mix-up resulting in the incorrect lot outer packaging of product.
- Root cause
- Labeling Change Control
- 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 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
- 1 unit
- Distribution
- US Nationwide distribution in the state of IL.
- Lot, serial or model codes
- REF#: AG740; UDI-DI: 00316837000299; Serial Number: 24GG298-022; Expiration Date: 28Jun2027;
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXA
- Firm FEI
- 1000121696
- Firm city
- North Brunswick
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28