# FDA recall Z-2626-2023

> **O&M HALYARD, INC.** · Class II · device recall initiated 2023-08-09.

## Product

FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827

## Reason for recall

One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.

## Distribution

US Distribution to States of: FL, GA, IA, IL, MO, MS, NE, OK, TN, TX, WI and OUS International to country of: Columbia

## Key facts

- **Recall number:** Z-2626-2023
- **Recalling firm:** O&M HALYARD, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-08-09
- **Report date:** 2023-09-27

- **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-2626-2023

## Citation

> AI Analytics. FDA recall Z-2626-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2626-2023. Source: US FDA. Licensed CC0.

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