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…
Read the official notice →- Date
- 2023-06-21
- Country
- United States
- Brand
- Noxbox
- Product
- NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
- Classification
- Class I
- Units
- Worldwide distribution - US Nationwide and the countries of Bahrain, Bolivia,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- 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
- 2026-10-07
USNOXBOX 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.
- 2026-09-23
- US
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.
- 2025-10-15
- US
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.
- US
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…
- 2025-09-17
- US
NOXBOX LTD recalls NOxBOXi Nitric Oxide Delivery System
Replacement of the internal Sample Pump due to high failure rates.
Other drugs & medical recalls in the United States
- 2023-06-21
- US
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The threads on posts stripping out when tensioned during application process.
FDA · DeviceNew Standard Device IncU.S. Nationwide distribution in the states of AZ, CT, OH, TX, VA.Official notice → - US
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FDA · DeviceApothecary Products, LLCWorldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO,…Official notice → - US
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The laser operation might fall under a higher laser class.
- US
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Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
- US
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