🔍 RecallPedia

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 to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A

Class I - Dangerous
🏥 Medical Devices Recalled: June 5, 2025 Waismed Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI: 0 7290008325059 Lot number: 2440043, 2440045, 2540046, 2540047
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Waismed Ltd.
Reason for Recall:
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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 to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A

Product Codes/Lot Numbers:

UDI: 0 7290008325059 Lot number: 2440043, 2440045, 2540046, 2540047

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2118-2025

Related Recalls

Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO 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. Component: N/A

Waismed

Class I - Dangerous

Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.

Jun 5, 2025 Other Medical Devices Nationwide View Details →

NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism that injects a trocar needle into the bone marrow of a patient and allows connection of syringe or IV administration set. The NIO-A is intended for adults above 12 years old and the NIO-P is intended for pediatric patients 3 - 12 years of age.

Waismed

Class I - Dangerous

WaisMed received a report in which during the operation of the NIO-A, the needle was not released from the device as expected. The device was placed on the floor and after several minutes the needle was released spontaneously. NIO-A and the NIO-P models have the same activation mechanism. However, none of the affected lots of the NIO-A are distributed in the US, and thus the company is only recalling a single lot of NIO-P in the US.

Aug 18, 2016 Surgical Instruments View Details →