Class I — NOXBOX LTD
| Recalling firm | NOxBOX Limited |
|---|---|
| Registered facility | NOXBOX LIMITED (the firm's only registered facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz). |
| Product | NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I |
| Quantity | 1667 units |
| Distribution | Domestic: TN |
| Initiated | 2025-09-09 |
| Classified | 2025-10-06 |
| Recall number | Z-0028-2026 |
| Initiation | Voluntary: 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 I recall — NOXBOX LTD (Z-0028-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97517/
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