Class II — NOXBOX LTD
| Recalling firm | NOxBOX Limited |
|---|---|
| Registered facility | NOXBOX LIMITED (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation. |
| Product | NOxBOXi Nitric Oxide Delivery System. |
| Quantity | 1,547 units |
| Distribution | US Nationwide distribution in the state of Georgia. |
| Initiated | 2026-08-19 |
| Classified | 2026-09-15 |
| Recall number | Z-3165-2026 |
| 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 II recall — NOXBOX LTD (Z-3165-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99621/
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