Z-0029-2026 Class I Ongoing

Recalled by NOXBOX LTD — Sittingbourne

Recall Details

Product Type
Devices
Report Date
October 15, 2025
Initiation Date
September 9, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1667 units

Product Description

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

Reason for Recall

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.

Distribution Pattern

Domestic: TN;

Code Information

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