Class II recall Z-3306-2026: NOXBOX LTD
Class II recall Z-3306-2026: NOXBOX LTD: NOXBOX LTD. Dated 28 days ago, it is in the active follow-up window. Score 62/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Free preview: all 14 published fields of this record are shown below. Locked: 499 related FDAPulse records and the 5-column CSV export.
| 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 |
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- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-07
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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62 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 28 days ago.
What is the FDAPulse record for Class II recall Z-3306-2026: NOXBOX LTD?
Class II device recall Z-3306-2026 by NOXBOX LTD: Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.
How does Class II recall Z-3306-2026: NOXBOX LTD compare to other FDAPulse records?
It is 28 days old, still within a typical 45-day follow-up window.
Class II recall Z-3306-2026 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-3306-2026 | 2026-10-07 | |
| Class II recall Z-3155-2026 | MA | 2026-10-07 |
| Class II recall Z-0232-2027 | 2026-10-28 | |
| Class II recall Z-0243-2027 | 2026-10-28 |
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