Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 ...
FDA Recall #Z-2118-2025 — Class II — June 5, 2025
Product Description
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
Reason for Recall
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Recalling Firm
Waismed Ltd. — Herzliya, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
7056 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.
Code Information
UDI: 0 7290008325059 Lot number: 2440043, 2440045, 2540046, 2540047
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.