RegWardenFDA facility compliance records
Recall

Class II — NOXBOX LTD

Recalling firmNOxBOX Limited
Registered facilityNOXBOX LIMITED (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonReplacement of the internal Sample Pump due to high failure rates.
ProductNOxBOXi Nitric Oxide Delivery System
Quantity1,667 units
DistributionUS Nationwide distribution in the state of TN.
Initiated2023-07-19
Classified2025-09-09
Recall numberZ-2544-2025
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — NOXBOX LTD (Z-2544-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97417/

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