[pending] Artegraft¿ Collagen Vascular Graft; REF: AG1015;
Pending LLM rewrite. Source: FDA_DEVICE Z-0289-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
The device was incorrectly packed in the wrong size labeled outer packaging.
The recalled product
- Product
- Artegraft¿ Collagen Vascular Graft; REF: AG1015;
- Manufacturer
- LeMaitre Vascular, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- REF: AG1015
- UDI-DI: 00316837000343
- Lot/Serial Number: 23MM581-016
Distribution
Distributed in 1 state:
- AR
Related recalls
Same category
- ModerateOneLIF Interbody Cage Inserter Attachment Failure Recall
FDA (Devices) · 2026-05-27
- HighOncology Kit With Extension Sets May Leak During Infusion Therapy
FDA (Devices) · 2026-05-27
- ModeratePhilips Allura X-ray Systems Deaeration Hose Degradation Recall
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Pacing Catheter Model D200F7 Recall Due to Leak Risk
FDA (Devices) · 2026-05-27
- ModerateSilastic Brand Foley Catheters recalled due to surface stain
FDA (Devices) · 2026-05-27