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
This recall is currently active, issued July 17, 2025. It was issued by Waismed Ltd. 11, Galgalei Ha-Plada Pob 12135 Herzliya Israel.
- Recall Initiated
- June 5, 2025
- Posted
- July 17, 2025
- Recall Number
- Z-2118-2025
- Quantity
- 7056 units (US)
- Official Source
- View on FDA website ↗
Reason for Recall
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Distribution
Worldwide distribution: US (nationwide) to state of: NC and OUS (international) countries of: Slovenia, Australia, Brazil, Estonia, South Africa, U. Arab Emirate, Greece, Panama, Singapore, Italy, Germany, Portugal, Spain, Ukraine, Lithuania, Chile, Poland, Germany, New Zealand, Montenegro, Switzerland, Argentina, Poland, Austria, Sweden, United Kingdom, Italy, France, Romania, Netherlands, Croatia, Lithuania, New Zealand, Japan, Cyprus, and Israel.
Lot / Code Info
UDI: 0 7290008325059 Lot number: 2440043, 2440045, 2540046, 2540047
Root Cause
Process change control
Action Taken
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.