FDA Device recall Z-2119-2025
Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO…
- FDA Device
- Class II
- ongoing
- Published 2025-07-23
On 2025-07-23 the FDA classified a Class II recall of Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO… by Waismed, citing due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2119-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-05 |
| Published | 2025-07-23 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Waismed |
| Distribution | US |
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 Proximal Tibia in adult patients, in emergent situations. Component: N/A
Reason
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Identifiers
| code_info | Lot Code: UDI: 07290008325073 Lot number: 2440044 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2119-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.