Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37400 |
| Brand Name: | NOXBOXi Nitric Oxide Monitor and Delivery System |
| Model: | NOxBOXi Intelligent Delivery and Monitor |
| Affected: | Product code: NOXBOX-1 |
| Software version: | |
| Recalling Organisation: | Keyport Ltd 431 Te Rapa Road HAMILTON |
| Contact Information: | |
| Manufacturer: | NOxBOX Ltd |
| Issue: | The manufacturer has identified an increased trend in complaints for oxygen leaks within the NOxMixer module of the NOxBOXi device due to failure of the tubing or tubing connection. The NOxMixer module is intended to deliver a continuous flow of nitric oxide (NO), mixed in line with oxygen (O2) for emergency applications and when manually ventilating a patient (i.e., during Emergency and Manual Bagging modes). This failure occurs inside the NOxMixer module when a leak develops in the internal oxygen tubing or the tubing connection at the elbow fitting upstream of the oxygen flowmeter. |
| Recall action type: | Correction |
| Recall action: | Product to be modified |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 31/8/2026 |
