FDA Medical devices recall ·
NOxBOXi Nitric Oxide Delivery System recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0028-2026
- Date
- (initiated September 9, 2025)
- Company / brand
- Noxbox Ltd
Unit 1, Sittingbourne, United Kingdom - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 1667 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Why was it recalled?
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).
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Numbers: (1) NOXBOXI (NBL (Manufacturer)), (2) REQNOXBOXI (Linde (U.S. Distributor)); UDI-DI: 05060541640009; All serial numbers.
Distribution
Domestic: TN
States: Tennessee
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0028-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.