FDA Medical devices recall ·
Artegraft¿ Collagen Vascular Graft recall
- Recall number
- Z-0289-2026
- Date
- (initiated September 25, 2025)
- Company / brand
- LeMaitre Vascular, Inc.
206 N Center Dr, North Brunswick, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1 unit
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Artegraft¿ Collagen Vascular Graft; REF: AG1015;
Why was it recalled?
The device was incorrectly packed in the wrong size labeled outer packaging.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
REF: AG1015; UDI-DI: 00316837000343; Lot/Serial Number: 23MM581-016;
Distribution
US distribution to the state of: AR
States: Arkansas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0289-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.