Recall Z-2119-2025 ยท FMI Needle, Hypodermic, Single Lumen
Waismed Ltd.
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
| Date | Jul 17, 2025 (initiated Jun 5, 2025) |
| Status | Open, Classified |
| Reason | Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion. |
| Root cause | Process change control |
| Action | 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 storag |
| Quantity | 516 units (US) |
| 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, Switzer |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211968 | NIO+ Adult Waismed, Ltd., Jul 22, 2021 |