Recall Z-3306-2026 ยท MRN Apparatus, Nitric Oxide Delivery
NOXBOX LTD
NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.
| Date | Sep 25, 2026 (initiated Sep 14, 2026) |
| Status | Open, Classified |
| Reason | Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors. |
| Root cause | Component design/selection |
| Action | On about 08/31/2026 NOXBOX initially notified its single distributor of the recall via emailed URGENT MEDCIAL DEVICE CORRECTION letter. The letter instructed distributors to examine inventory for affected units, complete and return the provided Distributor Response Form, arrange for the replacement of affected oxygen sensors, perform all preventive maintenance checks on NOxBOXi devices prior to distribution of units, ensure all applicable personnel are notified within the organization, notify all customers who have received affected units. Device users were instructed to examine inventory for |
| Quantity | 1,667 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 |