FDAFDA · Food and drugs·Recall number Z-2118-2025
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
Published July 23, 2025 · Recall initiated: June 5, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Waismed Ltd.
- Distributor
- 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
- UDI: 0 7290008325059 Lot number: 2440043, 2440045, 2540046, 2540047
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Israel
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