# FDA recall Z-2118-2025

> **Waismed Ltd.** · Class II · device recall initiated 2025-06-05.

## Product

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

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.

## Key facts

- **Recall number:** Z-2118-2025
- **Recalling firm:** Waismed Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-05
- **Report date:** 2025-07-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Herzliya, N/A, Israel

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2118-2025

## Citation

> AI Analytics. FDA recall Z-2118-2025. Retrieved 2026-07-10 from https://api.ai-analytics.org/recall/Z-2118-2025. Source: US FDA. Licensed CC0.

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