Waismed Ltd. recalls NIO+ Intraosseous Device Adult Model 105000908 due to potential stabilizer malfunction after deployment. This device is for emergency use in adult patients. Affected units have specific lot codes and were sold with a UDI.
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Waismed Ltd. is recalling NIO+ Intraosseous Device Adult Model 105000908 because a manufacturing error may cause the built-in stabilizer to not release properly after insertion. This could lead to improper device function during emergency use in adult patients.
The device's built-in stabilizer may not release correctly after deployment, potentially causing improper function during emergency use. This could affect the device's ability to provide safe access in critical medical situations.
Adult patients needing emergency intraosseous access in the proximal humerus or proximal tibia. The risk is highest for medical professionals using this device in emergency situations.
Check for the model number 105000908 on the device. Affected units have a specific lot code (2440044) and UDI (07290008325073). The device is for emergency use in adult patients.
Look for the model number 105000908 on the device to confirm if it is affected.
The recall indicates a potential manufacturing error that may cause the stabilizer not to release properly after deployment, so it is not recommended for use until the recall is addressed.
The recall does not specify a remedy, so contact Waismed Ltd. for further instructions.
Check for the model number 105000908 and lot code 2440044 or UDI 07290008325073.
We’ve drafted a message you can send NIO+ to request your refund or repair — edit it as you like.
Subject: Recall Z-2119-2025 — NIO+ NIO+ Hello, I own a NIO+ that is covered by recall Z-2119-2025 from NIO+. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
