Device recall
Z-2119-2025: Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog…
FDA device recall · Class II · Waismed Ltd.
Key facts
| Recall number (Z-number) | Z-2119-2025 |
|---|---|
| Recall event | 97061 |
| Product | Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intraosseous access device supplied Sterile and single use. Indicated for Intraosseous access to the Proximal humerus and… |
| Product code | FMI |
| Recalling firm | Waismed Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K211968 |
| FEI number | 3001316486 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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