Database updated: 3 November 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37767 |
| Brand Name: | NOXBOXi Nitric Oxide Monitor and Delivery System |
| Model: | Product Code - NOXBOX-I |
| Affected: | Serial number: NI103206, NI100931, NI101157, NI101195, NI103009, NI100792 |
| Software version: | |
| Recalling Organisation: | Keyport Ltd 431 Te Rapa Road HAMILTON |
| Contact Information: | |
| Manufacturer: | NOxBOX Ltd |
| Issue: | The manufacturer has identified a manufacturing issue affecting certain oxygen sensors. The issue may cause oxygen sensors to intermittently display irregular oxygen concentrations or cause the NOxBOXi device to fail the required oxygen sensor zero calibration. This sensor failure may be intermittent and may not be detected immediately following manufacture or during pre-use system and setup checks. Based on the design of the NOxBOXi device, the oxygen sensor is used solely to monitor the oxygen level in the sampled gas and is complimentary to other oxygen monitoring that might be used on a patient. It is not used by the device to automatically adjust or control oxygen delivery, nor is the monitored value used to control iNO delivery during Intelligent Delivery mode. |
| Recall action type: | Correction |
| Recall action: | Product to be exchanged |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 22/10/2026 |
