Class II U.S. Food and Drug Administration

LeMaitre Vascular, Inc. Artegraft Collagen Vascular Graft. Model/Catalog/Part recall: Devices were distributed with incorrect label without CE and UKCA mark

Recall published 1+ years ago

Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.

The hazard: Labelling or manufacturing-practice failure

A labelling or good-manufacturing-practice failure prompted this notice. Pharmacies and patients both rely on the printed carton being right.

What the notice says: Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.

Why it matters: The label, the strength printed on it, the barcode or the manufacturing records do not meet federal requirements. The practical danger is someone taking the wrong drug or the wrong dose while believing they have the right one.

Symptoms and when to call a doctor

If you may have taken a product that turned out to be a different drug or strength from the one on the label, call your prescriber, and call Poison Control on 1-800-222-1222 if you feel unwell. Describe what the pack said and what you actually took.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-0072-2026
Published
October 15, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
LeMaitre Vascular, Inc.
Product type
Medical devices
Units affected
10 units
Made in
United States
Lot / code info
Model/Catalog/Part Number, UDI-DI (lot Numbers): 1. AG630M, 00316837000015 (24H361-021, 24H361-022, 24HH359-016). 2. AG636M, 00316837000022 (24H380-009). 3. AG730M, 00316837000060 (24H380-014, 24H380-004). 4. AG740M, 00316837000084 (24H380-003, 24H380-002). 5. AG845M, 00316837000138 (24HH350-017, 24HH359-011). Expiration date: 28 Jul 2027.
UPC codes
00316837000015, 00316837000022, 00316837000060, 00316837000084, 00316837000138

Products covered by this recall

Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve as a substitute conduit for blood where bypass or replacement of occluded or diseased arterial segments is required or to establish a conduit for hemodialysis.

Check your product

The notice names 10 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00316837000015
  • 00316837000022
  • 00316837000060
  • 00316837000084
  • 00316837000138

Model or item number

On the rating label, the box or the instruction sheet.

  • AG630M
  • AG636M
  • AG730M
  • AG740M
  • UDI-DI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Labelling

LeMaitre Vascular, Inc. — A labelling or good-manufacturing-practice failure prompted this notice. Pharmacies and patients both rely on the printed carton being right.

  1. Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.
  2. Return the affected pack to the pharmacy for a replacement from a good lot.
  3. Report a mismatch to FDA MedWatch, especially if it reached you rather than being caught at the counter.
  4. If what you were dispensed does not match your prescription, call the pharmacy before taking another dose.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Company contact: LeMaitre Vascular, Inc. — 206 N Center Dr, North Brunswick, NJ, 08902-4246

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was LeMaitre Vascular, Inc. medical devices recalled?

Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card. Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00316837000015, 00316837000022, 00316837000060; model number AG630M, AG636M, AG730M. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.

Can I get my money back?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

Related recalls