# FDA recall Z-0729-2025

> **O&M HALYARD, INC.** · Class II · device recall initiated 2024-11-08.

## Product

O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask    Product Code: 47500

## Reason for recall

Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required.

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-0729-2025
- **Recalling firm:** O&M HALYARD, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-08
- **Report date:** 2025-01-01

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0729-2025

## Citation

> AI Analytics. FDA recall Z-0729-2025. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0729-2025. Source: US FDA. Licensed CC0.

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