LeMaitre Vascular, Inc.: Device Recall
Recall #Z-0034-2026 · 09/02/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0034-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- LeMaitre Vascular, Inc.
- Status
- Ongoing
- Date Initiated
- 09/02/2025
- Location
- North Brunswick, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28 units
Reason for Recall
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.
Product Description
Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;
Distribution Pattern
US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, MS, NC, ND, NJ, NY, OK, PA, TN, TX, VA, WA.
Other Recalls by LeMaitre Vascular, Inc.
- Class II: Risk 09/25/2025
- Class II: Risk 08/25/2025
- Class II: Risk 04/11/2025
- Class II: Risk 04/11/2025
- Class II: Risk 04/11/2025
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.