LeMaitre Vascular, Inc.: Device Recall

Recall #Z-0289-2026 · 09/25/2025

Class II: Risk

Recall Details

Recall Number: Z-0289-2026
Classification: Class II
Product Type: Device
Recalling Firm: LeMaitre Vascular, Inc.
Status: Ongoing
Date Initiated: 09/25/2025
Location: North Brunswick, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1 unit

Reason for Recall

The device was incorrectly packed in the wrong size labeled outer packaging.

Product Description

Artegraft¿ Collagen Vascular Graft; REF: AG1015;

Distribution Pattern

US distribution to the state of: AR

Other Recalls by LeMaitre Vascular, Inc.

Class II: Risk 09/02/2025

The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.
Class II: Risk 08/25/2025

Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
Class II: Risk 04/11/2025

During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Class II: Risk 04/11/2025

During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Class II: Risk 04/11/2025

During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).

View all recalls by LeMaitre Vascular, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.