# FDA recall Z-0446-2025

> **AVID Medical, Inc.** · Class II · device recall initiated 2024-09-20.

## Product

Halyard EP TRAY - Medical convenience kits  Model Number: VAST038-04

## Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients  surgical site undetected causing local reactions or possible foreign body reactions

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0446-2025
- **Recalling firm:** AVID Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-20
- **Report date:** 2024-11-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Toano, VA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0446-2025

## Citation

> AI Analytics. FDA recall Z-0446-2025. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0446-2025. Source: US FDA. Licensed CC0.

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