Artegraft Vascular Graft; REF#: AG740;

FDA device recall Z-1574-2026 · posted 2026-03-19 · Open, Classified

Recall details

Recalling firm

LeMaitre Vascular, Inc.

Reason for recall

Labeling mix-up resulting in the incorrect lot outer packaging of product.

Action taken

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

Root cause

Labeling Change Control

Status

Open, Classified

Product code

LXA

Quantity affected

1 unit

Distribution

US Nationwide distribution in the state of IL.

Date initiated

2026-02-10

Date posted

2026-03-19

Location

North Brunswick, NJ