# FDA recall Z-1667-2023

> **NOXBOX LTD** · Class I · device recall initiated 2023-05-03.

## Product

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

## Reason for recall

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 interruption in therapy which could lead to oxygen desaturation of the patient and associated complications.

## Distribution

Worldwide distribution - US Nationwide and the countries of Bahrain, Bolivia, Brazil,  Ecuador, Finland, France, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Kuwait,  Malaysia, Mexico, Netherlands, New Zealand, Panama, Saudi Arabia, Singapore,  South Africa, Spain, Taiwan, Turkey, UAE, United Kingdom.

## Key facts

- **Recall number:** Z-1667-2023
- **Recalling firm:** NOXBOX LTD
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2023-05-03
- **Report date:** 2023-06-21
- **Termination date:** 2024-10-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sittingbourne, N/A, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1667-2023

## Citation

> AI Analytics. FDA recall Z-1667-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1667-2023. Source: US FDA. Licensed CC0.

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