NIO-A Intraosseous Device (Waismed) – Stabilizer Deployment Problem (2025)
Improperly released stabilizer can compromise intraosseous device deployment.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Waismed Ltd. 11, Galgalei Ha-Plada Pob 12135 Herzliya Israel
Lot Codes / Batch Numbers
UDI: 0 7290008325059 Lot number: 2440043, 2440045, 2540046, 2540047
Products Sold
UDI: 0 7290008325059 Lot number: 2440043, 2440045, 2540046, 2540047
Waismed Ltd. 11, Galgalei Ha-Plada Pob 12135 Herzliya Israel is recalling Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Softwa due to Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026