Recall database

Apparatus, Nitric Oxide Delivery recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–3 of 3 recalls

Class IOngoingZ-0029-2026

NOXBOX LTD recalls NOxBOXi Nitric Oxide Delivery System

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.

Nitric Oxide Delivery Apparatus
Software design

NOXBOX LTDOct 15, 2025

Class IOngoingZ-0028-2026

NOXBOX LTD recalls NOxBOXi Nitric Oxide Delivery System

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.…

Nitric Oxide Delivery Apparatus
Software design

NOXBOX LTDOct 15, 2025

Class IIOngoingZ-2544-2025

NOXBOX LTD recalls NOxBOXi Nitric Oxide Delivery System

Replacement of the internal Sample Pump due to high failure rates.

Nitric Oxide Delivery Apparatus
Component design/selection

NOXBOX LTDSep 17, 2025