Class I — NOXBOX LTD
| Recalling firm | NOxBOX Limited |
|---|---|
| Registered facility | NOXBOX LIMITED (the firm's only registered facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts. |
| 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-0029-2026 |
| 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-0029-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97516/
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