NOXBOX recalls NOxBOXi Nitric Oxide Delivery System (Model NOXBOX-I) due to potential dose fluctuations when device settings are incorrect. Affected users should contact manufacturer for details.
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).
NOXBOX is recalling its NOxBOXi Nitric Oxide Delivery System (Model NOXBOX-I) because improper device settings can cause inconsistent medication delivery. This may lead to incorrect dosing for patients using the system.
The device may deliver inconsistent medication doses if the flow through the sensor is below 0.5 LPM. This can happen when ventilators have low service pressures (less than 3.0 PSI), large pressure differences (over 5.0 cm H2O), or high breathing rates (300 breaths per minute).
Patients using the NOxBOXi Nitric Ox:ide Delivery System with Model NOXBOX-I are affected. Those with specific ventilator settings that cause low pressure or high flow rates are at higher risk.
Check for model numbers NOXBOX-I or NOXBOXI on the device. The product was sold with UDI-DI code 05060541640009 and all serial numbers.
Reach out to NOXBOX LTD for specific instructions on how to verify your device model and next steps.
The recalled device is model NOXBOX-I (also listed as NOXBOXI).
The device may deliver inconsistent medication doses if ventilator settings are incorrect, such as low service pressures, large pressure differences, or high breathing rates.
Check for model numbers NOXBOX-I or NOXBOXI on the device. The product was sold with UDI-DI code 05060541640009 and all serial numbers.
We’ve drafted a message you can send NOXBOX to request your refund or repair — edit it as you like.
Subject: Recall Z-0028-2026 — NOXBOX NOXBOX Hello, I own a NOXBOX that is covered by recall Z-0028-2026 from NOXBOX. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
