Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0034-2026·Announced 2025-10-08

Collagen vascular grafts recalled over unapproved bovine raw material supplier

LeMaitre Vascular is recalling 28 Artegraft Collagen Vascular Grafts because the bovine carotid arteries used to make them came from a supplier not reviewed and approved by the appropriate regulatory authority.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 because the record describes a regulatory approval gap in the raw material supply chain rather than an identified product defect or reported harm.

Plain-English summary

Artegraft Collagen Vascular Grafts, model numbers AG 616, AG 630, AG 636, AG 640, AG 645, AG 715, AG 730, AG 735, AG 740, AG 745, AG 750, AG 830, AG 840, AG 1015 and AG 1030, are being recalled.

The bovine carotid arteries used to produce the affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.

The recall covers 28 units, distributed in California, Connecticut, Florida, Georgia, Illinois, Massachusetts, Mississippi, North Carolina, North Dakota, New Jersey, New York, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia and Washington. The FDA has classified the action as Class II.

The enforcement record describes a supplier approval gap rather than a defect found in the grafts themselves, and reports no injuries. Facilities holding affected model and lot numbers should follow LeMaitre's instructions.

The recalled product

Product: Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;
Manufacturer: LeMaitre Vascular, Inc.
Category: Medical Device — Vascular graft
Hazard: unapproved-supplier
regulatory-noncompliance
raw-material
Affected units: 28

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 (20)

Model Numbers: (1) AG 616
(2) AG 630
(3) AG 636
(4) AG 640
(5) AG 645
(6) AG 715
(7) AG 730
(8) AG 735
(9) AG 740
(10) AG 745
(11) AG 750
(12) AG 830
(13) AG 840
(14) AG 1015
(15) AG 1030
UDI-DIs: (1) 00316837000213
(2) 00316837000220
(3) 00316837000237
(4) 00316837000244
(5) 00316837000251

Distribution

Distributed nationwide across the United States.

The notice also names 17 states specifically:

Same manufacturer · LeMaitre Vascular, Inc.

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