Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2119-2025 — 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

U.S. FDA — Device Enforcement · Israel · 2025-06-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2119-2025
Date of alert
2025-06-05
Country / jurisdiction
Israel
Risk level
Class II
Risk type
recall
Brand
Waismed Ltd.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07290008325073
Reported risk: Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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