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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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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

NOxBOXi Nitric Oxide Delivery System Recalled for Sample Pump Failure

Agency Publication Date: September 9, 2025
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Summary

NOXBOX LTD has recalled approximately 1,667 units of the NOxBOXi Nitric Oxide Delivery System (Model NOXBOXI) because the internal sample pump has shown high failure rates. This defect requires the sample pump to be replaced to ensure the device can properly monitor and deliver nitric oxide therapy. No injuries or incidents have been reported in connection with this issue, and the manufacturer is initiating corrections to fix the problem.

Risk

Failure of the internal sample pump can prevent the system from accurately measuring or delivering the required dose of nitric oxide. This can lead to an interruption in respiratory therapy, potentially resulting in serious health complications for patients who depend on the device for stabilized breathing.

What You Should Do

  1. This recall affects the NOxBOXi Nitric Oxide Delivery System, Model NOXBOXI, identifying with UDI 05060541640009 and various serial numbers.
  2. Check your device's identification label for Model NOXBOXI and the specific serial number. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product. Contact the manufacturer, NOXBOX LTD, or your authorized distributor to arrange for a replacement of the internal sample pump or for other corrective actions.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

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

Affected Products

Product: NOxBOXi Nitric Oxide Delivery System
Model / REF:
NOXBOXI
Serial Numbers (1667):
NI102738
NI103021
NI103146
NI101560
NI101059
NI102922
NI101034
NI102152
NI102854
NI101289
NI102957
NI102642
NI101960
NI102163
NI101717
NI102928
NI101146
NI101209
NI102128
NI101751
NI101743
NI102266
NI101813
NI102037
NI102079
NI102850
NI100850
NI101221
NI101708
NI101744
NI101879
NI101905
NI101948
NI102410
NI101208
NI101354
NI101940
NI102117
NI102338
NI101002
NI101729
NI102094
NI102310
NI102676
NI102888
NI102683
NI102933
NI102537
NI101594
NI101958
UDI:
05060541640009

Replacement of the internal Sample Pump due to high failure rates.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97417
Status: Active
Manufacturer: NOXBOX LTD
Sold By: Authorized medical device distributors
Manufactured In: United Kingdom
Units Affected: 1,667 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.