FDA Device recall Z-0028-2026
NOxBOXi Nitric Oxide Delivery System
- FDA Device
- Class I
- ongoing
- Published 2025-10-15
On 2025-10-15 the FDA classified a Class I recall of NOxBOXi Nitric Oxide Delivery System by Noxbox, citing 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.….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0028-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-09-09 |
| Published | 2025-10-15 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Noxbox |
| Distribution | TN |
Product
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
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).
Identifiers
| code_info | Model Numbers: (1) NOXBOXI (NBL (Manufacturer)), (2) REQNOXBOXI (Linde (U.S. Distributor)); UDI-DI: 05060541640009; All serial numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0028-2026%22
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