FDA recall Z-0289-2026
LeMaitre Vascular, Inc. · Class II · device
Product
Artegraft¿ Collagen Vascular Graft; REF: AG1015;
Reason for recall
The device was incorrectly packed in the wrong size labeled outer packaging.
Distribution
US distribution to the state of: AR
Key facts
- Status
- Ongoing
- Initiation date
- 2025-09-25
- Report date
- 2025-10-29
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- North Brunswick, NJ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0289-2026