FDA Medical devices recall ·
NOxBOXi Nitric Oxide Delivery System recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0029-2026
- 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?
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.
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-0029-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.