Quick Facts at a Glance
- Recall Date
- September 9, 2025
- Hazard Level
- HIGH
- Brand
- NOXBOX
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- NOXBOX
- Product type
- Nitric Oxide Delivery System
- Model numbers
- NOXBOX-I, NBL, REQNOXBOXI, UDI-DI: 05060541640009
- Sold at
- Unknown
- Where affected
- TN
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 9, 2025
Reported by FDA DEVICE
October 15, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact NOXBOX LTD or your healthcare provider for instructions. Notification method: Letter
About This Product
The NOxBOXi Nitric Oxide Delivery System is used to deliver inhaled nitric oxide in clinical settings, supporting certain respiratory therapies.
Why This Is Dangerous
The hazard arises from an internal fault triggered by rapid button presses, potentially leading to misoperation or diagnostic errors during use.
Industry Context
This recall is not identified as part of a broader industry pattern.
Real-World Impact
Immediate use restrictions may be necessary in clinical environments. Hospitals and patients may need to halt therapy until replacement guidance is provided.
Practical Guidance
How to identify if yours is affected
- Verify device model NOXBOX-I, NBL, REQNOXBOXI
- Check UDI-DI: 05060541640009 on the device label
- Compare with recall documentation to confirm eligibility for recall actions
Where to find product info
Details are in the recall notice available from FDA enforcement pages and manufacturer communications
What timeline to expect
Refund or replacement processing typically 4-8 weeks after confirmation
If the manufacturer is unresponsive
- Document all contact attempts with NOXBOX LTD
- Escalate to hospital risk management and local regulatory authorities if needed
How to prevent similar issues
- Establish a rapid-response protocol for device warnings and UI faults
- Verify device software and hardware before patient use
- Maintain an updated inventory of NOXBOXi devices and serial numbers
Documentation advice
Keep the recall notice, serial numbers, model numbers, photos of labeling, and correspondence with the manufacturer
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Product Details
Model numbers: NOXBOX-I, NBL, REQNOXBOXI, UDI-DI: 05060541640009 Where sold: Domestic, Tennessee (TN) When sold: Unknown Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Recall affects 1,667 units
- Models include NOXBOX-I, NBL, REQNOXBOXI; UDI-DI: 05060541640009
- Distributed in Tennessee; recall status ACTIVE
- Hazard: internal fault from rapid UI button presses
- Action: stop use immediately; follow manufacturer instructions
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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