FDA Medical Device Recalls (openFDA)
LeMaitre Vascular, Inc.: Artegraft Collagen Vascular Graft; REF: AG1015;
- Recall number
- Z-0289-2026
- Recalling firm
- LeMaitre Vascular, Inc.
- Product
- Artegraft Collagen Vascular Graft; REF: AG1015;
- Status
- Open, Classified
- Initiated
- 2025-09-25
- Posted
- 2025-10-23
- Terminated
- not on file
- Reason
- The device was incorrectly packed in the wrong size labeled outer packaging.
- Root cause
- Packaging change control
- Action
- 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.
- Quantity
- 1 unit
- Distribution
- US distribution to the state of: AR
- Lot, serial or model codes
- REF: AG1015; UDI-DI: 00316837000343; Lot/Serial Number: 23MM581-016;
- 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