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.

Read the official notice →
Date
2026-09-23
Country
United States
Brand
Noxbox
Product
NOxBOXi Nitric Oxide Delivery System.
Classification
Class II
Units
US Nationwide distribution in the state of Georgia.
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Noxbox recalls

  1. 2026-10-07
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    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. 2025-10-15
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    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 →
  5. US
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    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 →
  6. 2025-09-17
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    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 →
  8. 2023-06-21
  9. US
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    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 →
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