NIO-A and NIO+ Intraosseous Devices Recalled for Deployment Failure Risk

Agency Publication Date: July 17, 2025

Summary

Waismed Ltd. is recalling approximately 7,572 NIO Intraosseous Devices, including the NIO-A and NIO+ adult models, due to a manufacturing error. The built-in stabilizer in these devices may fail to release properly after being inserted into a patient. These sterile, single-use devices are spring-based tools used to provide emergency bone access in the humerus or tibia of adult patients when traditional intravenous access is not possible.

Risk

If the device's stabilizer fails to release after deployment, it can prevent the medical tool from functioning correctly during critical emergency procedures. This failure could delay life-saving medical treatment, although no injuries or incidents have been reported to date.

What You Should Do

This recall involves NIO-A and NIO+ Intraosseous Devices for adults, which are sterile, spring-based emergency medical devices manufactured by Waismed Ltd.
Identify affected units by checking the lot numbers and Unique Device Identifier (UDI) printed on the product packaging. Affected NIO-A units have model number 105000603, UDI 07290008325059, and lot numbers 2440043, 2440045, 2540046, or 2540047. Affected NIO+ units have model number 105000908, UDI 07290008325073, and lot number 2440044.
Stop using the recalled devices immediately to prevent potential deployment failures during medical procedures.
Contact Waismed Ltd. or your medical distributor to arrange for the return, replacement, or correction of the affected units.
Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding this medical device recall.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: NIO Intraosseous Device Adult (NIO-A)

Variants: Adult, Single Use, Sterile

Model / REF:

105000603

Lot Numbers:

2440043

2440045

2540046

2540047

UDI:

07290008325059

Recall number Z-2118-2025; 7,056 units affected in the US.

Product: NIO Intraosseous Device Adult (NIO+)

Variants: Adult, Single Use, Sterile

Model / REF:

105000908

Lot Numbers:

2440044

UDI:

07290008325073

Recall number Z-2119-2025; 516 units affected in the US.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97061

Status: Active

Manufacturer: Waismed Ltd.

Sold By: medical distributors

Manufactured In: Israel

Units Affected: 2 products (7056 units (US); 516 units (US))

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves NIO-A and NIO+ Intraosseous Devices for adults, which are sterile, spring-based emergency medical devices manufactured by Waismed Ltd.

Identify affected units by checking the lot numbers and Unique Device Identifier (UDI) printed on the product packaging. Affected NIO-A units have model number 105000603, UDI 07290008325059, and lot numbers 2440043, 2440045, 2540046, or 2540047. Affected NIO+ units have model number 105000908, UDI 07290008325073, and lot number 2440044.

Stop using the recalled devices immediately to prevent potential deployment failures during medical procedures.

Contact Waismed Ltd. or your medical distributor to arrange for the return, replacement, or correction of the affected units.

Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding this medical device recall.

Affected Products

Product: NIO Intraosseous Device Adult (NIO-A)

Variants: Adult, Single Use, Sterile

Model / REF:

105000603

Lot Numbers:

2440043

2440045

2540046

2540047

UDI:

07290008325059

Recall number Z-2118-2025; 7,056 units affected in the US.

Product: NIO Intraosseous Device Adult (NIO+)

Variants: Adult, Single Use, Sterile

Model / REF:

105000908

Lot Numbers:

2440044

UDI:

07290008325073

Recall number Z-2119-2025; 516 units affected in the US.