Reported Jul 23, 2025 · Ongoing
Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A…
Waismed Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Waismed Ltd. · 11, Galgalei Ha-Plada · Herzliya, N/A · N/A
Is this the product you have?
- Brand NameNIO+
- Product NameNIO Intraosseous
- Device Adult Model/Catalog Number105000908
- Software VersionN/A
- Product DescriptionNIO devices are a spring-based, automatic intraosseous access device supplied Sterile and single use. Indicated for Intraosseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations
- ComponentN/A
- Lot codes and dates
- Lot CodeUDI: 07290008325073
- Lot number2440044
- Amount recalled
- 516 units (US)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- NC
Why it was recalled
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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