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Z-2118-2025 Class II Ongoing

Recalled by Waismed Ltd. — Herzliya, N/A

FDA device recall Z-2118-2025 was initiated by Waismed Ltd. on June 5, 2025 and is designated Class II. Reason for recall: Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion. The recall status is ongoing. Affected quantity: 7056 units (US).

Recall Details

Product Type: Devices
Report Date: July 23, 2025
Initiation Date: June 5, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7056 units (US)

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.

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.

Code Information

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