Unrated Medical device recall · FDA · Published September 2, 2025

LeMaitre Artegraft Collagen Vascular Grafts Recall: Unapproved Raw Material Risk

LeMaitre Vascular recalls Artegraft Collagen Vascular Grafts with model numbers AG 616-1030 due to unapproved raw material from supplier. Affected items may pose health risks if used in medical procedures.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0034-2026Medical device LeMaitre Vascular ›

Recall notice

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

Take action

Contact the company

Recalling firmLeMaitre Vascular, Inc.206 N Center Dr · North Brunswick, NJ 08902-4246

✎ GovInfoNow plain-language explainer

LeMaitre Vascular is recalling Artegraft Collagen Vascular Grafts with specific model numbers because the raw materials used in production were sourced from a supplier not approved by regulatory authorities. This could lead to health risks if the grafts are used in medical procedures. Read more at govinfonow.com/recall/51493-lemaitre-artegraft-collagen-vascular-grafts-recall-unapproved-raw-material-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/51493-lemaitre-artegraft-collagen-vascular-grafts-recall-unapproved-raw-material-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0034-2026

Cite this page

“LeMaitre Artegraft Collagen Vascular Grafts Recall: Unapproved Raw Material Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51493-lemaitre-artegraft-collagen-vascular-grafts-recall-unapproved-raw-material-risk. Based on FDA recall #Z-0034-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0034-2026%22&limit=1).

The FDA announced on September 2, 2025, that LeMaitre Vascular is recalling Artegraft Collagen Vascular Grafts due to sourcing issues with raw materials. The bovine carotid arteries used in the impacted grafts came from a supplier not reviewed and approved by the appropriate regulatory authority.

How to tell if you have it

Brand: LeMaitre Vascular
Product: 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, AG 1030
UDI-DIs: 00316837000213, 00316837000220, 00316837000237, 00316837000244, 00316837000251, 00316837000268, 00316837000275, 00316837000282, 00316837000299, 00316837000305, 00316837000312, 00316837000367, 00316837000329, 00316837000343, 00316837000350
Serial Numbers: 23DD203-019, 23DD203-046, 23DD203-024, 23DD203-029, 23DD203-045, 23DD203-018, 23DD203-004, 23DD203-021, 23DD203-044, 23DD203-038, 23DD203-039, 23DD203-011, 23DD203-032, 23DD203-031, 23DD203-043, 23DD203-040, 23DD203-030, 23DD203-037, 23DD203-035, 23DD203-033, 23DD203-034, 23DD203-036, 23DD203-022, 23DD203-023, 23DD203-017, 23DD203-027, 23KK498-014, 23DD203-026
Quantity: 28 units
Distribution: US Nationwide in CA, CT, FL, GA, IL, MA, MS, NC, ND, NJ, NY, OK, PA, TN, TX, VA, WA

The hazard

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

Context

GovInfoNow's records show LeMaitre Vascular, Inc. has 12 other recalls on record since June 19, 2018. Other recent recalls of similar products include Artegraft Vascular Graft Recall Due to Labeling Mix-Up (February 10, 2026), LeMaitre Artegraft Collagen Vascular Graft Recall: Wrong Size Packaging (September 25, 2025), and LeMaitre Artegraft Vascular Graft Recall: Missing Labels and Patient Information (August 25, 2025). Other recent recalls of similar products include Intervascular Cardioroot Vascular Grafts May Fail Water Permeability Test (August 12, 2026), Davol Avitene Ultrafoam Hemostat Recall: Foreign Matter Risk (March 25, 2026), and Cerapedics PearMatrix P-15 Bone Graft Recall: Incorrect Expiration Date (December 29, 2025).

How to tell if you have this one

Check for model numbers AG 616 through AG 1030 on the grafts. Also look for the UDI-DIs starting with 00316837000213 and serial numbers beginning with 23DD203 or 23KK498.

Brand
LeMaitre Vascular
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the model number, UDI-DI, and serial number on the graft to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 17 states.

FDA distribution: “US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, MS, NC, ND, NJ, NY, OK, PA, TN, TX, VA, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Connecticut, Florida, Georgia, Illinois, Massachusetts, Mississippi, New Jersey, New York, North Carolina, North Dakota, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia, Washington.

Recall timeline

FDA published this recall 36 days after the firm started it.

Sep 2, 2025Firm started the recall
Oct 2, 2025FDA classified it Class II
Oct 8, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/51493-lemaitre-artegraft-collagen-vascular-grafts-recall-unapproved-raw-material-risk">LeMaitre Artegraft Collagen Vascular Grafts Recall: Unapproved Raw Material Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0034-2026 (September 2, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0034-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.