Waismed Ltd.: Medical Device Recall in 2025 - (Recall #: Z-2118-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: June 5, 2025

Date Posted: July 23, 2025

Recall Number: Z-2118-2025

Event ID: 97061

Reason for Recall:

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

Status: Ongoing

Product Quantity: 7056 units (US)

Code Information:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated