Recall Z-2119-2025— Waismed Ltd.
Class II · Ongoing
Class II FDA medical device recall by Waismed Ltd., initiated 2025-06-05. It names one FDA 510(k) clearance: K211968. 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..
- Recalling firm
- Waismed Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-06-05
- Firm location
- Herzliya, N/A, Israel
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Data sourced from openFDA. This site is unofficial and independent of the FDA.