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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices

NOxBOXi Nitric Oxide Delivery Systems Recalled for Software Fault

Agency Publication Date: October 6, 2025
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Summary

NOxBOX LTD is recalling 1,667 units of the NOxBOXi Nitric Oxide Delivery System, specifically model NOXBOX-I. The recall was initiated because the device can experience an unexpected internal fault or system diagnostic error if the user interface buttons are pressed in rapid succession without waiting for the device to respond. This error can result in an interruption of the nitric oxide therapy being delivered to the patient. Consumers should stop using affected devices and contact the manufacturer or their distributor for a solution.

Risk

The software fault causes the device to stop delivering nitric oxide, which is critical for patients receiving respiratory support. This sudden interruption in therapy could lead to serious or life-threatening health consequences for patients who depend on the system for oxygenation.

What You Should Do

  1. This recall affects all serial numbers of the NOxBOXi Nitric Oxide Delivery System, which may be labeled as model numbers NOXBOX-I, NOXBOXI, or REQNOXBOXI with UDI-DI 05060541640009.
  2. Identify your device by checking the model and serial number on the manufacturer's label located on the device.
  3. Stop using the recalled device. Contact the manufacturer or your distributor, such as Linde, to arrange for a return, replacement, or software correction.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: NOxBOXi Nitric Oxide Delivery System
Model / REF:
NOXBOX-I
NOXBOXI
REQNOXBOXI
Serial Numbers:
All serial numbers
UDI:
05060541640009

NOXBOXI is the manufacturer model code; REQNOXBOXI is the distributor (Linde) model code.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97516
Status: Active
Manufacturer: NOXBOX LTD
Sold By: Linde
Manufactured In: United Kingdom
Units Affected: 1667 units
Distributed To: Tennessee

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 ยท 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.