Brand Name: NIO+ Product Name: NIO Intraosseous Device recall
Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO devices…
Why was Brand Name: NIO+ Product Name: NIO Intraosseous Device recalled?
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Code: UDI: 07290008325073 Lot number: 2440044
- Product
- Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO devices…
- Recalling firm
- Waismed Ltd.
- Quantity
- 516 units (US)
- 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.
- Recall date
- July 23, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)