Device recall
Z-2259-2024: The Non-Sterile Flyte hood covers the user s head and neck region and is…
FDA device recall · Class II · Stryker Corporation
Key facts
| Recall number (Z-number) | Z-2259-2024 |
|---|---|
| Recall event | 94755 |
| 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… |
| Product code | OEA |
| Recalling firm | Stryker Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3015967359 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database