NOXBOX LTD Recalls
3 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (3)
- Class I
September 9, 2025
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
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.
- Class I
September 9, 2025
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
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).
- Class II
July 19, 2023
NOxBOXi Nitric Oxide Delivery System
Replacement of the internal Sample Pump due to high failure rates.
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.