RegWardenFDA facility compliance records
Company

LeMaitre Vascular, Inc.

4 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2025: 3 recalls; 2026: 1 recalls201720182019202020212022202320243202512026
  • Recalls (4)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2026-02-10
    Labeling mix-up resulting in the incorrect lot outer packaging of product.
  • Class IIOngoing2025-09-25
    The device was incorrectly packed in the wrong size labeled outer packaging.
  • Class IIOngoing2025-09-02
    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.
  • Class IIOngoing2025-08-25
    Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “LeMaitre Vascular, Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9006148-lemaitre-vascular-inc/

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