FDAHealthSeptember 9, 2025
NOXBOX LTD — NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
⚠️ 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.
Is this relevant to me?
- Geography
- TN
- Source agency
- FDA
- Category
- Health
- Published
- September 9, 2025
Domestic: TN;
What's affected?
- Product
- NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
- Brand
- NOXBOX LTD
- Lot code
- Model Numbers: (1) NOXBOXI (NBL (Manufacturer)), (2) REQNOXBOXI (Linde (U.S. Distributor)); UDI-DI: 05060541640009; All serial numbers.
Additional details
Model Numbers: (1) NOXBOXI (NBL (Manufacturer)), (2) REQNOXBOXI (Linde (U.S. Distributor)); UDI-DI: 05060541640009; All serial numbers.
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 1667 units.
Get Health recall alerts
Delivered to your inbox. Free. No account required.