Quick Facts at a Glance
- Recall Date
- September 25, 2025
- Hazard Level
- HIGH
- Brand
- LeMaitre Vascular
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- LeMaitre Vascular
- Product type
- Vascular graft
- Model numbers
- REF: AG1015, UDI-DI: 00316837000343, Lot/Serial Number: 23MM581-016
- Sold at
- Unknown
- Where affected
- AR
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 25, 2025
Reported by FDA DEVICE
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
The device was incorrectly packed in the wrong size labeled outer packaging.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact LeMaitre Vascular, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
Artegraft Collagen Vascular Grafts are used in vascular surgery to repair or replace blood vessels. They are implanted by healthcare professionals in hospitals.
Why This Is Dangerous
The hazard stems from incorrect packing of the graft in the wrong size on outer packaging, which may lead to selecting an inappropriate graft size for a procedure.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
The immediate impact is procedural risk if a mismatched graft is used. Hospitals may need to verify inventory and communicate with surgeons about correct sizing.
Practical Guidance
How to identify if yours is affected
- Compare device packaging label with the recall notice
- Verify model numbers and lot/serial against AG1015 in the recall list
- Check the UFIs and packaging for the correct size labeling
Where to find product info
Recall notices, model AG1015 details, and UDI can be found in the FDA enforcement report Z-0289-2026 and the manufacturer letters.
What timeline to expect
Recalls for medical devices commonly require 4-8 weeks for process and replacement or remediation actions.
If the manufacturer is unresponsive
- Document all communications with the manufacturer
- Escalate to hospital risk management or patient safety offices
- Contact the FDA recall program if the manufacturer is unresponsive
How to prevent similar issues
- Verify device size labeling before implantation
- Maintain up-to-date recall communications from manufacturers
- Train staff on identifying mislabeled packaging
- Cross-check UDI codes during instrument set preparation
Documentation advice
Keep the recall letter, product labels, packaging, and any correspondence as part of clinical records
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Product Details
Product: Artegraft Collagen Vascular Graft Brand: LeMaitre Vascular Model: REF AG1015 UDI-DI: 00316837000343 Lot/Serial: 23MM581-016 Distribution: US to Arkansas Recall Date: 2025-09-25 Status: ACTIVE Manufacturer: LeMaitre Vascular, Inc.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Lot/Serial 23MM581-016
- Distributed to Arkansas facilities
- Recall date 2025-09-25, status ACTIVE
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