FDA Device recall Z-2259-2024
The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially available gowns
- FDA Device
- Class II
- ongoing
- Published 2024-07-10
On 2024-07-10 the FDA classified a Class II recall of The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially available gowns by Stryker, citing expired Products distributed to customers.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2259-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-03 |
| Published | 2024-07-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Stryker |
| Distribution | US |
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
Expired Products distributed to customers
Identifiers
| code_info | GTIN: 07613327514063 Lot Number: 20040649 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2259-2024%22
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