BEUDAMED
    FDA Enforcement Class II Ongoing

    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

    Recall: Z-2118-2025 · Reported July 23, 2025

    Enforcement

    Recall Number
    Z-2118-2025
    Event ID
    97061
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Waismed Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 23, 2025
    Initiation Date
    June 5, 2025
    Classification Date
    July 17, 2025
    Address
    11, Galgalei Ha-Plada, Pob 12135, Herzliya, N/A, N/A, Israel

    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

    Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.

    Code Info

    UDI: 0 7290008325059 Lot number: 2440043, 2440045, 2540046, 2540047

    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.

    Quantity

    7056 units (US)