RegWardenFDA facility compliance records
Recall

Class II — NOXBOX LTD

Recalling firmNOxBOX Limited
Registered facilityNOXBOX LIMITED (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonPotential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.
ProductNOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.
Quantity1,667 units
DistributionUS Nationwide distribution in the state of Georgia.
Initiated2026-09-14
Classified2026-09-25
Recall numberZ-3306-2026
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-14. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — NOXBOX LTD (Z-3306-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-14. https://regwarden.com/recall/99816/

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