Noxbox recalls

6 official recalls and safety alerts involving Noxbox since 2023-06, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Noxbox or the relevant agency.

  1. 2026-10-07
  2. US
    Drugs & medicalClass II

    NOXBOX LTD recalls NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.

    Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.

    FDA · DeviceNOXBOX LTDUS Nationwide distribution in the state of Georgia.Official notice →
  3. 2026-09-23
  4. US
    Drugs & medicalClass II

    NOXBOX LTD recalls NOxBOXi Nitric Oxide Delivery System.

    Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.

    FDA · DeviceNOXBOX LTDUS Nationwide distribution in the state of Georgia.Official notice →
  5. 2025-10-15
  6. US
    Drugs & medicalClass I

    NOXBOX LTD recalls 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.

    FDA · DeviceNOXBOX LTDDomestic: TN;Official notice →
  7. US
    Drugs & medicalClass I

    NOXBOX LTD recalls 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…

    FDA · DeviceNOXBOX LTDDomestic: TNOfficial notice →
  8. 2025-09-17
  9. US
    Drugs & medicalClass II

    NOXBOX LTD recalls NOxBOXi Nitric Oxide Delivery System

    Replacement of the internal Sample Pump due to high failure rates.

    FDA · DeviceNOXBOX LTDUS Nationwide distribution in the state of TN.Official notice →
  10. 2023-06-21
  11. US
    Drugs & medicalClass I

    NOXBOX LTD recalls NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device

    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…

    FDA · DeviceNOXBOX LTDWorldwide distribution - US Nationwide and the countries of Bahrain, Bolivia,…Official notice →