FDA recall, , Moderate risk
Artegraft Vascular Graft
The Artegraft Vascular Graft has a labeling mix-up resulting in incorrect lot outer packaging.
Summary by Recall Canary from the FDA notice
What happened
LeMaitre Vascular, Inc., of North Brunswick, New Jersey, recalled one unit of its Artegraft Vascular Graft, REF# AG740, because of a labeling mix-up that resulted in incorrect lot outer packaging. The company began the recall on February 10, 2026, and the FDA added it to its Enforcement Report on March 19, 2026. The product was distributed in Illinois.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI matches.
A UDI-DI is the device identifier printed with the barcode on the device label.
Artegraft Vascular Graft; REF#: AG740;
- UDI-DI
- 00316837000299
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the state of Illinois.
- Company
- LeMaitre Vascular, Inc.North Brunswick, New Jersey
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98409
- Recall number
- Z-1574-2026
- Quantity recalled
- 1 unit
All recalls from LeMaitre Vascular, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
