Medical Device Recall: NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
NOXBOX LTD · September 9, 2025
Reason for Recall
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).
Distribution
Domestic: TN
States Affected
TN
Quantity Affected
1667 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0028-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.