Z-0289-2026Class II

Artegraft Collagen Vascular Graft; REF: AG1015

Name: Z-0289-2026 Artegraft Collagen Vascular Graft; REF: AG1015
Creator: LeMaitre Vascular, Inc.
Published: 2025-09-25
License: https://open.fda.gov/license/

LeMaitre Vascular Inc. / initiated 2025-09-25 / Open, Classified / root cause: packaging

FDA source

LeMaitre Vascular, Inc. began a recall of Artegraft Collagen Vascular Graft; REF: AG1015 on 2025-09-25. FDA classified it as Class II and gives the reason as "The device was incorrectly packed in the wrong size labeled outer packaging". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0289-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-25
Posted: 2025-10-23
Recalling firm: LeMaitre Vascular Inc.
Product: Artegraft Collagen Vascular Graft; REF: AG1015;
Product code: LXA Tissue Graft Of 6mm And Greater
Reason for recall: The device was incorrectly packed in the wrong size labeled outer packaging.
Root cause tag: packaging
FDA 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 [email protected]. 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: [email protected] or at 732-422-8333 Monday through Friday, 8:00AM to 4:30 PM, Eastern Time.
Quantity in commerce: 1 unit
Distribution: US distribution to the state of: AR
Product codes and lots: REF: AG1015; UDI-DI: 00316837000343; Lot/Serial Number: 23MM581-016;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0289-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0289-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-23

Product code LXA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)