# FDA recall Z-0029-2026

> **NOXBOX LTD** · Class I · device recall initiated 2025-09-09.

## Product

NOxBOXi Nitric Oxide Delivery System;  Model Numbers: NOXBOX-I

## Reason for recall

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.

## Distribution

Domestic: TN;

## Key facts

- **Recall number:** Z-0029-2026
- **Recalling firm:** NOXBOX LTD
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-09
- **Report date:** 2025-10-15

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0029-2026

## Citation

> AI Analytics. FDA recall Z-0029-2026. Retrieved 2026-07-31 from https://api.ai-analytics.org/recall/Z-0029-2026. Source: US FDA. Licensed CC0.

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