Waismed Ltd. recalls Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 10…

Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.

On June 05, 2025, WaisMed issued an "Urgent: Medical Device Recall" notification to affected consignees via E-Mail. WaisMed asked consignees to take the follow actions: 1. Healthcare providers should immediately discontinue use of affected devices and consider alternative intraosseous access products to ensure continuity of patient care without compromising treatment timelines in critical situations. 2. Immediately discontinue, quarantine and remove all NIO A and NIO+ devices from the affected lots from all points of use, including emergency kits, crash carts, ambulances, and clinical storage areas. 3. Verify your inventory against the specific lot numbers listed in this recall notice to identify all affected products. 4. Share and post this Product Recall letter within your facility network. 5. Forward to any customers you may have distributed the product to ensure awareness. 6. Ensure the contents of this Product Recall are read and understood by those within your organization. 7. Please complete the attached Recall Acknowledgement and Receipt Form and return it to: RECALLS@SAFEGUARDMEDICAL.COM or mail to: Waismed Ltd. 10 Amal St. Afek Industrial Park, Rosh Ha'yin 4809234, Israel. Any questions directly associated with this recall should be directed to the: Recall Coordinator or International Director Quality and Regulatory Affairs via email: vigilanceil@safeguardmedical.com, phone: +972-9-9517444 or website: safeguardmedial.com.

• FDA enforcement recordOfficial FDA database entry for Z-2119-2025
• FDA 510(k) clearance · K211968The device's official FDA premarket clearance record
• FDA device classification · FMIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5570The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Waismed Ltd.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.