RegWardenFDA facility compliance records
Recall

Class II — LeMaitre Vascular, Inc.

Recalling firmLeMaitre Vascular, Inc.
Registered facilityLEMAITRE VASCULAR, INC. (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonLabeling mix-up resulting in the incorrect lot outer packaging of product.
ProductArtegraft Vascular Graft; REF#: AG740;
Quantity1 unit
DistributionUS Nationwide distribution in the state of IL.
Initiated2026-02-10
Classified2026-03-19
Recall numberZ-1574-2026
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — LeMaitre Vascular, Inc. (Z-1574-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98409/

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