# FDA recall Z-2259-2024

> **Stryker Corporation** · Class II · device recall initiated 2024-06-03.

## Product

The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially available gowns. The hood is donned after the Flyte helmet and before the gown, such that the hood is securely tucked inside the gown. The hood attaches to and covers the helmet and air is drawn into the helmet through a filter located on the top-backside of the hood. The filtered air is delivered into the helmet and the disposable does not inhibit adjustment of helmet settings/functions. Catalog Number: 0408-800-000NS

## Reason for recall

Expired Products distributed to customers

## Distribution

US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan.

## Key facts

- **Recall number:** Z-2259-2024
- **Recalling firm:** Stryker Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-06-03
- **Report date:** 2024-07-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Portage, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2259-2024

## Citation

> AI Analytics. FDA recall Z-2259-2024. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-2259-2024. Source: US FDA. Licensed CC0.

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