FDA Device recall Z-3306-2026
NOxBOXi Nitric Oxide Delivery System
- FDA Device
- Class II
- ongoing
- Published 2026-10-07
On 2026-10-07 the FDA classified a Class II recall of NOxBOXi Nitric Oxide Delivery System by Noxbox, citing potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3306-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-09-14 |
| Published | 2026-10-07 |
| Last updated | 2026-10-13 05:30 UTC |
| Company | Noxbox |
| Distribution | US |
Product
NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.
Reason
Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.
Identifiers
| code_info | Model Number: NOXBOX-I. UDI-DI: 05060541640009. Serial Numbers: NI100825, NI100833, NI100839, NI100840, NI100841, NI100…Model Number: NOXBOX-I. UDI-DI: 05060541640009. Serial Numbers: NI100825, NI100833, NI100839, NI100840, NI100841, NI100847, NI100848, NI100849, NI100850, NI100851, NI100852, NI100855, NI100858, NI100859, NI100861, NI100862, NI100865, NI100866, NI100868, NI100869, NI100872, NI100873, NI100875, NI100876, NI100878, NI100879, NI100880, NI100881, NI100882, NI100883, NI100884, NI100885, NI100886, NI100887, NI100888, NI100895, NI100932, NI100935, NI100942, NI100948, NI100949, NI100953, NI100961, NI100975, NI100976, NI100978, Serial Number, NI100980, NI100983, NI100985, NI100986, NI100987, NI100989, NI100990, NI100991, NI100993, NI100994, NI100996, NI100997, NI100999, NI101001, NI101002, NI101003, NI101004, NI101005, NI101006, NI101008, NI101009, NI101010, NI101011, NI101012, NI101013, NI101014, NI101015, NI101017, NI101018, NI101019, NI101024, NI101026, NI101028, NI101029, NI101030, NI101031, NI101033, NI101034, NI101035, NI101038, NI101039, NI101041, NI101042, NI101044, NI101048, NI101049, S |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-13 05:30 UTC. Current status: ongoing.
Other recalls by Noxbox
- NOxBOXi Nitric Oxide Delivery System
FDA Device · Class II · 2026-09-23 · 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-3306-2026%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.