# FDA recall Z-0072-2026

> **LeMaitre Vascular, Inc.** · Class II · device recall initiated 2025-08-25.

## Product

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.

## Reason for recall

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

## Distribution

No US distribution. International distribution to Great Britian and Switzerland.

## Key facts

- **Recall number:** Z-0072-2026
- **Recalling firm:** LeMaitre Vascular, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-25
- **Report date:** 2025-10-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Brunswick, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0072-2026

## Citation

> AI Analytics. FDA recall Z-0072-2026. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/Z-0072-2026. Source: US FDA. Licensed CC0.

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