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
Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz).
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: E-Mail
About This Product
The NOxBOXi Nitric Oxide Delivery System is used to administer nitric oxide to patients requiring gas exchange support, typically in critical care settings.
Why This Is Dangerous
If total sensor flow falls below 0.5 LPM, flow readings can be inaccurate, leading to dose fluctuations. Certain ventilator settings worsen this risk.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Clinicians must monitor dosing accuracy and ensure device usage aligns with recall guidance to avoid potential patient harm.
Practical Guidance
How to identify if yours is affected
- 1) Locate the NOxBOXi device.
- 2) Check model numbers: NOXBOX-I, NBL, REQNOXBOXI.
Where to find product info
FDA enforcement page and manufacturer recall notice.
What timeline to expect
Refund or replacement timelines are not specified. Hospitals should expect manufacturer updates and FDA guidance.
If the manufacturer is unresponsive
- Document all attempts to contact NOXBOX LTD.
- Escalate to hospital compliance or medical device oversight if the manufacturer is unresponsive.
How to prevent similar issues
- Verify device compatibility with current ventilator settings during procurement.
- Monitor for recall updates from FDA and NOXBOX LTD.
- Train clinical staff on recognizing dosing irregularities in nitric oxide delivery systems.
Documentation advice
Keep recall notices, model numbers, UDI-DI, and correspondences with the manufacturer; photograph devices and serial numbers where possible.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Model numbers: NOXBOX-I, NBL, REQNOXBOXI. UDI-DI: 05060541640009. Sold in the United States, domestic distribution in Tennessee. Recall date: 2025-09-09. Report date: 2025-10-15. Units recalled: 1,667. Manufacturer: NOXBOX LTD.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Models NOXBOX-I, NBL, REQNOXBOXI; UDI-DI 05060541640009
- Flow sensor minimum 0.5 LPM
- Hazard includes dose fluctuations with LifePulse HFJV or ventilators at <3.0 PSI, ΔP >5 cm H2O, or 5
- Recall date 2025-09-09; Report date 2025-10-15
- Distribution in Tennessee (Domestic)
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.
