LeMaitre Vascular Artegraft Vascular Graft Class II Recall
Summary
FDA issued a Class II recall for LeMaitre Vascular's Artegraft Vascular Graft (REF#: AG740) due to a labeling mix-up causing incorrect lot outer packaging. The affected products were distributed nationwide with presence in Illinois. Healthcare facilities with this product should identify and quarantine affected inventory.
What changed
FDA classified a Class II recall for LeMaitre Vascular's Artegraft Vascular Graft (REF#: AG740) initiated due to a labeling mix-up resulting in incorrect lot outer packaging of the product. This labeling error creates potential for product mix-ups during dispensing or administration.
Healthcare facilities and distributors that received Artegraft Vascular Graft products should immediately check lot numbers on outer packaging against product labeling, quarantine any discrepant inventory, and contact LeMaitre Vascular to arrange return or replacement of affected products.
What to do next
- Identify affected Artegraft Vascular Graft products by lot number
- Quarantine any products with potentially incorrect lot labeling
- Contact LeMaitre Vascular for return/replacement instructions
Archived snapshot
Apr 11, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
LeMaitre Vascular, Inc.
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1574-2026 · 20260325 · Ongoing
Product
Artegraft Vascular Graft; REF#: AG740;
Reason for Recall
Labeling mix-up resulting in the incorrect lot outer packaging of product.
Distribution
US Nationwide distribution in the state of IL.
Source: openFDA Enforcement API
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