Class IIOngoingZ-1574-2026
LeMaitre Vascular, Inc. recalls Artegraft Vascular Graft
Labeling mix-up resulting in the incorrect lot outer packaging of product.
LeMaitre Vascular, Inc…NJMar 25, 2026
Tissue Graft Of 6mm And Greater recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–4 of 4 recalls
Class IIOngoingZ-0289-2026
LeMaitre Vascular, Inc. recalls Artegraft¿ Collagen Vascular Graft
The device was incorrectly packed in the wrong size labeled outer packaging.
LeMaitre Vascular, Inc…NJOct 29, 2025
Class IIOngoingZ-0072-2026
LeMaitre Vascular, Inc. recalls Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
LeMaitre Vascular, Inc…NJOct 15, 2025
Class IIOngoingZ-0034-2026
LeMaitre Vascular, Inc. recalls Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616
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.
LeMaitre Vascular, Inc…NJOct 8, 2025