NOXBOX LTD

FDA Regulatory Profile

NOXBOX LTD appears in FDA public data with 4 recalls — including 3 Class I (most serious) —, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0028-2026, Class I) was initiated on September 9, 2025.

Summary

Total Recalls
4 (3 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0028-2026Class INOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-ISeptember 9, 2025
Z-0029-2026Class INOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-ISeptember 9, 2025
Z-2544-2025Class IINOxBOXi Nitric Oxide Delivery SystemJuly 19, 2023
Z-1667-2023Class INOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery DeviceMay 3, 2023