Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0029-2026

September 09, 2025

Class I

Product summary

Firm
NOXBOX LTD
Event
Event 97516
Status
Ongoing
Classification
Class I
Quantity
1667 units
Official record key
device-enforcement:Z-0029-2026

Official wording

Reason: 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.

Code information: Model Numbers: (1) NOXBOXI (NBL (Manufacturer)), (2) REQNOXBOXI (Linde (U.S. Distributor)); UDI-DI: 05060541640009; All serial numbers.

Distribution pattern: Domestic: TN;

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.