Home / Recalls / Medical Devices
NOXBOX LTD recalls NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Recalled October 15, 2025 · FDA recall Z-0028-2026 · NOXBOX
Hazard
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). · FDA Class I
Units
1667 units
Sold at
Domestic: TN
Description
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).
Product
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Manufacturer(s)
NOXBOX LTD
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →