Reported Oct 8, 2025 · Ongoing
Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG…
LeMaitre Vascular, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LeMaitre Vascular, Inc. · 206 N Center Dr · North Brunswick, NJ · 08902-4246
Is this the product you have?
- Artegraft
- Collagen Vascular Grafts Model Numbers
(1) AG 616(2) AG 630(3) AG 636(4) AG 640(5) AG 645(6) AG 715(7) AG 730(8) AG 735(9) AG 740(10) AG 745(11) AG 750(12) AG 830(13) AG 840(14) AG 1015(15) AG 1030
- Lot codes and dates
3 of 3 products
Products covered by this recall # Barcodes Product as published 1 Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030 2 003168370002130031683700022000316837000237003168370002440031683700025100316837000268003168370002750031683700028200316837000299003168370003050031683700031200316837000367003168370003290031683700034300316837000350UDI-DIs: (1) 00316837000213, (2) 00316837000220, (3) 00316837000237, (4) 00316837000244, (5) 00316837000251, (6) 00316837000268, (7) 00316837000275, (8) 00316837000282, (9) 00316837000299, (10) 00316837000305, (11) 00316837000312, (12) 00316837000367, (13) 00316837000329, (14) 00316837000343, (15) 00316837000350 3 Serial Numbers: (1) 23DD203-019, 23DD203-046, (2) 23DD203-024, 23DD203-029, (3) 23DD203-045, (4) 23DD203-018, (5) 23DD203-004, (6) 23DD203-021, 23DD203-044, 23DD203-038, 23DD203-039, 23DD203-011, 23DD203-032, 23DD203-031, 23DD203-043, (7) 23DD203-040, 23DD203-030, 23DD203-037, (8) 23DD203-035, 23DD203-033, (9) 23DD203-034, (10) 23DD203-036, (11) 23DD203-022, 23DD203-023, (12) 23DD203-017, (13) 23DD203-027, (14) 23KK498-014, (15) 23DD203-026 - Amount recalled
- 28 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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