FDA Recalls NIO Intraosseous Device for Stabilizer Release Failure
Waismed Ltd. is recalling the NIO Intraosseous Device Adult due to a manufacturing defect where the built-in stabilizer may not release properly after deployment, potentially affecting emergency medical access procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with no reported hospitalizations or injuries. The device failure poses a potential risk to emergency medical procedures, but no actual harm has been documented, placing this in the 'High' severity category as a risk-of-harm product without reported injury.
Plain-English summary
The FDA has announced a recall of the NIO Intraosseous Device Adult (Model 105000908, Lot 2440044) manufactured by Waismed Ltd. The device is a spring-based, automatic intraosseous access device used for emergency bone marrow access in adult patients. Due to a manufacturing error, the device's built-in stabilizer may not release properly after deployment and insertion.
This defect could prevent proper device function during emergency medical procedures. The device is intended for rapid intraosseous access to the proximal humerus or proximal tibia in adult patients during emergency situations. 516 units have been distributed in the United States and internationally.
Affected patients and healthcare facilities with this lot should cease use and contact Waismed Ltd. or the FDA with questions about their devices. Healthcare providers should verify the lot number on affected devices and discontinue use of any units matching the recalled lot code.
The recalled product
- Product
- 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 t
- Manufacturer
- Waismed Ltd.
- Hazard
- device-malfunction
- stabilizer-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Code: UDI: 07290008325073 Lot number: 2440044
Distribution
Distributed nationwide across the United States.
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