FDA Device recall Z-3165-2026
NOxBOXi Nitric Oxide Delivery System
- FDA Device
- Class II
- ongoing
- Published 2026-09-23
On 2026-09-23 the FDA classified a Class II recall of NOxBOXi Nitric Oxide Delivery System by Noxbox, citing potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3165-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-19 |
| Published | 2026-09-23 |
| Last updated | 2026-09-29 05:30 UTC |
| Company | Noxbox |
| Distribution | US |
Product
NOxBOXi Nitric Oxide Delivery System.
Reason
Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.
Identifiers
| code_info | UDI-DI 05060541640009. Identification Number (Serial Number): NM100825 (NI100825), NM100833 (NI100833), NM100839 (NI100…UDI-DI 05060541640009. Identification Number (Serial Number): NM100825 (NI100825), NM100833 (NI100833), NM100839 (NI100839), NM100840 (NI100840), NM100841 (NI100841), NM100847 (NI100847), NM100848 (NI100848), NM100849 (NI100849), NM100850 (NI100850), NM100851 (NI100851), NM100852 (NI100852), NM100855 (NI100855), NM100858 (NI100858), NM100859 (NI100859), NM100861 (NI100861), NM100862 (NI100862), NM100865 (NI100865), NM100866 (NI100866), NM100868 (NI100868), NM100869 (NI100869), NM100872 (NI100872), NM100873 (NI100873), NM100875 (NI100875), NM100876 (NI100876), NM100878 (NI100878), NM100879 (NI100879), NM100880 (NI100880), NM100881 (NI100881), NM100882 (NI100882), NM100883 (NI100883), NM100884 (NI100884), NM100885 (NI100885), NM100886 (NI100886), NM100887 (NI100887), NM100888 (NI100888), NM100895 (NI100895), NM100932 (NI100932), NM100935 (NI100935), NM100942 (NI100942), NM100948 (NI100948), NM100949 (NI100949), NM100953 (NI100953), NM100961 (NI100961), NM100975 (NI100975), NM100976 (NI10 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-29 05:30 UTC. Current status: ongoing.
Other recalls by Noxbox
- NOxBOXi Nitric Oxide Delivery System
FDA Device · Class II · 2026-10-07 · Noxbox - NOxBOXi Nitric Oxide Delivery System
FDA Device · Class I · 2025-10-15 · Noxbox - NOxBOXi Nitric Oxide Delivery System
FDA Device · Class I · 2025-10-15 · Noxbox - NOxBOXi Nitric Oxide Delivery System
FDA Device · Class II · 2025-09-17 · Noxbox - NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
FDA Device · Class I · 2023-06-21 · Noxbox
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3165-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.