The Non-Sterile Flyte hood covers the user s head and neck region and… — Class II medical device recall Z-2259-2024
Ongoing recall by Stryker Corporation, reported 2024-07-10, distributed nationwide. Expired Products distributed to customers
| Recall number | Z-2259-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2024-06-03 |
| Classified | 2024-07-03 |
| Reported by FDA | 2024-07-10 |
| Distributed | Nationwide (US) |
| Quantity | 4 units |
| UPC / GTIN / UDI-DI | 07613327514063 |
| Lot numbers | 20040649 |
| Model numbers | 0408-800-000NS |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2259-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.