Device recall
Z-1469-2025: Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and…
FDA device recall · Class II · Stryker Corporation
Key facts
| Recall number (Z-number) | Z-1469-2025 |
|---|---|
| Recall event | 96393 |
| Product | Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL |
| Product code | NHB |
| Recalling firm | Stryker Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K070715 |
| FEI number | 3015967359 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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