FDA Device recall Z-0029-2026
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 the unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to resp….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0029-2026 |
| 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
The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts.
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-0029-2026%22
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