# Class II recall Z-3306-2026: NOXBOX LTD

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3306-2026 |
| Recalling firm | NOXBOX LTD |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I. |
| Reason | Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors. |
| Quantity | 1,667 units |
| Distribution | US Nationwide distribution in the state of Georgia. |
| Recall initiated | 2026-09-14 |
| Reported | 2026-10-07 |
| Firm location | Sittingbourne, United Kingdom |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 28 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3306-2026%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.