NIO Intraosseous Device Adult recalled due to stabilizer release failure
The NIO Intraosseous Device Adult manufactured by Waismed Ltd. may not properly release its built-in stabilizer after insertion due to a manufacturing error, potentially complicating emergency intraosseous 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: This is a Class II medical device recall with a confirmed manufacturing defect affecting a critical function (stabilizer release). While no injuries or illnesses have been reported, the defect creates a risk of harm by potentially preventing device removal during emergency procedures. Per the rubric, a risk-of-harm product without reported injury scores at most 3.
Plain-English summary
Waismed Ltd. is recalling the NIO Intraosseous Device Adult (model 105000603) due to a manufacturing defect affecting the device's built-in stabilizer. The stabilizer may not release properly after the device is deployed and inserted, which could prevent timely device removal during emergency intraosseous access procedures.
7,056 units were distributed in the United States nationwide. The affected lots are: 2440043, 2440045, 2540046, and 2540047. Additional units were distributed internationally to Slovenia, Australia, Brazil, Estonia, South Africa, United Arab Emirates, Greece, Panama, Singapore, Italy, Germany, Portugal, Spain, Ukraine, Lithuania, Chile, Poland, New Zealand, Montenegro, Switzerland, Argentina, Austria, Sweden, United Kingdom, France, Romania, Netherlands, Croatia, Japan, Cyprus, and Israel.
Healthcare facilities should discontinue use of affected devices and contact Waismed Ltd. and the FDA for guidance on returns and replacements. Verify lot numbers before using any NIO Intraosseous Device Adult units in inventory.
The recalled product
- 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 t
- Manufacturer
- Waismed Ltd.
- Hazard
- device-malfunction
- stabilizer-release-failure
- improper-device-removal
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 (4)
- UDI: 0 7290008325059 Lot number: 2440043
- 2440045
- 2540046
- 2540047
Distribution
Distributed nationwide across the United States.
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