Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Recalled by Waismed Ltd. Due to Due to manufacturing error, Intraosseous device built-in stabilizer...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Waismed Ltd. directly.
Affected Products
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
Quantity: 7056 units (US)
Why Was This Recalled?
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Waismed Ltd.
Waismed Ltd. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report