Waismed Ltd.: Device Recall

Recall #Z-2119-2025 · 06/05/2025

Class II: Risk

Recall Details

Recall Number
Z-2119-2025
Classification
Class II
Product Type
Device
Recalling Firm
Waismed Ltd.
Status
Ongoing
Date Initiated
06/05/2025
Location
Herzliya, N/A, Israel
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
516 units (US)

Reason for Recall

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

Product Description

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

Distribution Pattern

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.

Other Recalls by Waismed Ltd.

View all recalls by Waismed Ltd. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.