# FDA recall Z-0028-2026

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

## Product

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

## Reason for recall

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 been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz).

## Distribution

Domestic: TN

## Key facts

- **Recall number:** Z-0028-2026
- **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-0028-2026

## Citation

> AI Analytics. FDA recall Z-0028-2026. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-0028-2026. Source: US FDA. Licensed CC0.

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