LeMaitre Artegraft Collagen Vascular Graft Recall: Wrong Size Packaging
LeMaitre Vascular recalls Artegraft Collagen Vascular Graft (REF: AG1015) due to incorrect packaging size labeling. Affected units may have wrong size labels on outer packaging.
Lower-risk recall
The device was incorrectly packed in the wrong size labeled outer packaging.
Contact the company
What happened, in plain English
LeMaitre Vascular is recalling Artegraft Collagen Vascular Grafts with reference number AG1015 because they were incorrectly packed in the wrong size labeled outer packaging. This could lead to confusion about the correct size for medical use. Read more at govinfonow.com/recall/51229-lemaitre-artegraft-collagen-vascular-graft-recall-wrong-size-packaging.
Source Summary by GovInfoNow · govinfonow.com/recall/51229-lemaitre-artegraft-collagen-vascular-graft-recall-wrong-size-packaging · Updated August 10, 2026 · FDA enforcement record: FDA #Z-0289-2026
Cite this page
“LeMaitre Artegraft Collagen Vascular Graft Recall: Wrong Size Packaging.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/51229-lemaitre-artegraft-collagen-vascular-graft-recall-wrong-size-packaging. Based on FDA recall #Z-0289-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0289-2026%22&limit=1).
Why it’s dangerous
The grafts were incorrectly packed in the wrong size labeled outer packaging. This means the packaging might show the wrong size for the graft, potentially causing confusion during medical procedures.
Who’s affected
Patients using Artegraft Collagen Vascular Grafts with reference number AG1015 are likely affected. Medical professionals who use these grafts for vascular procedures may be at risk if they rely on the packaging labels.
How to tell if you have this one
Check for the reference number AG1015 on the packaging. The product has a unique identifier 00316837000343 and lot number 23MM581-016.
- Brand
LeMaitre Vascular- Category
Medical device
What to do — step by step
Check Packaging Label
Look for the reference number AG1015 on the outer packaging to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed in Arkansas.
FDA distribution: “US distribution to the state of: AR” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arkansas.
Recall timeline
FDA published this recall 34 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-0289-2026 (September 25, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0289-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 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.