FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-2119-2025
- Recalling firm
- Waismed Ltd.
- 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
- Status
- Open, Classified
- Initiated
- 2025-06-05
- Posted
- 2025-07-17
- Terminated
- not on file
- 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 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.
- 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, Switzerland, Argentina, Poland, Austria, Sweden, United Kingdom, Italy, France, Romania, Netherlands, Croatia, Lithuania, New Zealand, Japan, Cyprus, and Israel.
- Lot, serial or model codes
- Lot Code: UDI: 07290008325073 Lot number: 2440044
- 510(k) numbers
- ["K211968"]
- PMA numbers
- not on file
- Product code
- FMI
- Firm FEI
- 3001316486
- Firm city
- Herzliya
- Firm state
- not on file
- Firm country
- Israel
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28