# FDA recall Z-0289-2026

> **LeMaitre Vascular, Inc.** · Class II · device recall initiated 2025-09-25.

## Product

Artegraft¿ Collagen Vascular Graft;  REF: AG1015;

## Reason for recall

The device was incorrectly packed in the wrong size labeled outer packaging.

## Distribution

US distribution to the state of: AR

## Key facts

- **Recall number:** Z-0289-2026
- **Recalling firm:** LeMaitre Vascular, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-25
- **Report date:** 2025-10-29

- **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-0289-2026

## Citation

> AI Analytics. FDA recall Z-0289-2026. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0289-2026. Source: US FDA. Licensed CC0.

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