Waismed Ltd. recalls NIO Intraosseous Device Adult Model 105000603 due to manufacturing error causing stabilizer to not release properly after deployment. Affected units have lot numbers 2440043, 2440045, 2540046, 2540047.
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 105000603 because a manufacturing error may cause the built-in stabilizer to not release properly after insertion. This could lead to improper device function during use, potentially causing complications for patients needing emergency intraosseous access.
The device's built-in stabilizer may not release properly after deployment and insertion due to a manufacturing error. This could result in the device failing to function correctly during emergency procedures, potentially causing complications for patients needing rapid access to the bone.
Adult patients requiring emergency intraosseous access to the proximal humerus or proximal tibia. Medical professionals using the device are most at risk of improper function during critical procedures.
Check for the model number 105000603 on the device. Affected units have lot numbers 2440043, 2440045, 2540046, or 2540047. The product is a sterile, single-use device for emergency intraosseous access in adults.
Verify the model number is 105000603 and the lot number is one of 2440043, 2440045, 2540046, or 2540047.
The recall indicates a potential manufacturing error that could cause the stabilizer to not release properly, so it is not recommended for use until the recall is addressed.
Check the model number and lot number to see if it is affected. If it is, contact Waismed Ltd. for further instructions.
Affected units have model number 105000603 and lot numbers 2440043, 2440045, 2540046, or 2540047.
We’ve drafted a message you can send NIO-A to request your refund or repair — edit it as you like.
Subject: Recall Z-2118-2025 — NIO-A NIO-A Hello, I own a NIO-A that is covered by recall Z-2118-2025 from NIO-A. 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.
