Recall Z-0289-2026— LeMaitre Vascular, Inc.

Name: FDA recall Z-0289-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-25

Class II · Ongoing

Class II FDA medical device recall by LeMaitre Vascular, Inc., initiated 2025-09-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Artegraft¿ Collagen Vascular Graft; REF: AG1015;. Reason: The device was incorrectly packed in the wrong size labeled outer packaging..

Recalling firm: LeMaitre Vascular, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-09-25
Firm location: North Brunswick, NJ, United States

Product description

Artegraft¿ Collagen Vascular Graft; REF: AG1015;

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.