Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult… — Class II medical device recall Z-2118-2025
Ongoing recall by Waismed Ltd., reported 2025-07-23, distributed nationwide. Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deploym
| Recall number | Z-2118-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Waismed Ltd., Herzliya, N/A, Israel |
| Recall initiated | 2025-06-05 |
| Classified | 2025-07-17 |
| Reported by FDA | 2025-07-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BR, CH, CL, CY, DE, EE, ES, FR, GB, GR, HR, IL, IT, JP, LT, NL, NZ, PA, PL, PT, RO, SE, SG, SI, UA, ZA |
| Quantity | 7,056 units |
| UPC / GTIN / UDI-DI | 07290008325059 |
| Lot numbers | 2440043, 2440045, 2540046, 2540047 |
| Model numbers | 105000603 |
Product
Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intra-osseous access device supplied Sterile and single use. Indicated for Intra-osseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A
Reason for recall
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2118-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.