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Waismed Ltd. recalls Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A
Recalled July 23, 2025 · FDA recall Z-2118-2025 · Waismed
Hazard
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion. · FDA Class II
Units
7056 units (US)
Sold at
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.
Description
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
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
Manufacturer(s)
Waismed Ltd.
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →