# FDA recall Z-1461-2024

> **O&M HALYARD, INC.** · Class III · device recall initiated 2024-02-20.

## Product

HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)

## Reason for recall

Product was mislabeled as a Surgical Cap at its dispenser level.

## Distribution

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, HI, MN, MO, MT, SD, TN, TX, and WA. The country of Canada.

## Key facts

- **Recall number:** Z-1461-2024
- **Recalling firm:** O&M HALYARD, INC.
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-20
- **Report date:** 2024-04-10

- **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-1461-2024

## Citation

> AI Analytics. FDA recall Z-1461-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1461-2024. Source: US FDA. Licensed CC0.

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