RegWardenFDA facility compliance records
Company

NOxBOX Limited

5 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2023: 2 recalls; 2025: 2 recalls; 2026: 1 recalls2017201820192020202120222202320242202512026
  • Recalls (5)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2026-08-19
    Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.
  • Class IOngoing2025-09-09
    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 …
  • Class IOngoing2025-09-09
    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 IIOngoing2023-07-19
    Replacement of the internal Sample Pump due to high failure rates.
  • Class ITerminated2023-05-03
    Device may experience malfunctions due to misalignment of the check valve in the manifold. If the device fails, there is a risk of nitric oxide leak, oxygen gas leak, or earlier cylinder gas changeover than expected or not at all. In a worst case scenario, there may be an interru…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “NOxBOX Limited — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10058545-noxbox-limited/

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