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Urgent Enforcement Amended Final

LeMaitre Vascular Artegraft Vascular Graft Class II Recall

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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

  1. Identify affected Artegraft Vascular Graft products by lot number
  2. Quarantine any products with potentially incorrect lot labeling
  3. Contact LeMaitre Vascular for return/replacement instructions

Archived snapshot

Apr 11, 2026

GovPing 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

Named provisions

Artegraft Vascular Graft

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Last updated

Classification

Agency
FDA
Filed
March 25th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
Z-1574-2026

Who this affects

Applies to
Medical device makers Healthcare providers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical device recall Product labeling
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Product Safety Healthcare

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