Recall Z-0028-2026 ยท MRN Apparatus, Nitric Oxide Delivery
NOXBOX LTD
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
| Date | Oct 6, 2025 (initiated Sep 9, 2025) |
| Status | Open, Classified |
| Reason | 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. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz). |
| Root cause | Software design |
| Action | On September 9, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: - Use the instructions provided to troubleshoot the device. - Complete and return the attached response form to Linde Gas & Equipment as instructed on the form. Recalling firm actions: NOxBOX Ltd. is in the process of developing a new software version that will include a modification to the software to resolve this issue, which will be released pending required regulatory review and approval. Once the software version is released, NOxBOX Ltd. will coordinate with Linde Gas & Equipment in |
| Quantity | 1667 units |
| Distribution | Domestic: TN |
| 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 |