Recall Z-3165-2026 ยท MRN Apparatus, Nitric Oxide Delivery
NOXBOX LTD
NOxBOXi Nitric Oxide Delivery System.
| Date | Sep 15, 2026 (initiated Aug 19, 2026) |
| Status | Open, Classified |
| Reason | Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation. |
| Root cause | Device Design |
| Action | NOxBOX notified its single US distributor on about 08/19/2026 via emailed "URGENT MEDICAL DEVICE CORRECTION" letter. Consignees were informed of the issue of potential oxygen leaks within the NOxMixer module of the NOxBOXi device due to failure of the tubing or tubing connection. This may lead to interruption in nitric oxide therapy, which could lead to oxygen desaturation and necessitate medical intervention. Distributors were instructed to examine inventory for affected units, complete and return the Distributor Response Form provided and NOxBOX will provide work instructions and material t |
| Quantity | 1,547 units |
| Distribution | US Nationwide distribution in the state of Georgia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171696 | NOxBOXi Nitric Oxide Delivery System Praxair Distribution, Inc., Oct 2, 2018 |
| K201339 | The NOxBOXi Nitric Oxide Delivery System Praxair, Inc., Jun 19, 2020 |
| K220898 | NOxBOXi Nitric Oxide Delivery System Linde Gas & Equipment, Inc., Apr 27, 2022 |
| K231823 | NOxBOXi Nitric Oxide Delivery System Linde Gas & Equipment, Inc., Aug 11, 2023 |
| K233251 | NOxBOXi Nitric Oxide Delivery System Linde Gas & Equipment, Inc., May 23, 2024 |