Device recall
Z-0969-2025: Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
FDA device recall · Class II · Adept Medical Ltd
Key facts
| Recall number (Z-number) | Z-0969-2025 |
|---|---|
| Recall event | 95942 |
| Product | Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321; |
| Product code | ETD |
| Recalling firm | Adept Medical Ltd |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K061058 |
| FEI number | 3006098219 |
At a glance
- 1–9 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