Recall Z-3306-2026— NOXBOX LTD
Class II · Ongoing
Class II FDA medical device recall by NOXBOX LTD, initiated 2026-09-14. It names 5 FDA 510(k) clearances: K233251, K231823, K220898 and 2 more. 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..
- Recalling firm
- NOXBOX LTD
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-09-14
- Firm location
- Sittingbourne, United Kingdom
510(k) clearances named in this recall
5 on FDA's record- K233251 — NOxBOXi Nitric Oxide Delivery System
- K231823 — NOxBOXi Nitric Oxide Delivery System
- K220898 — NOxBOXi Nitric Oxide Delivery System
- K201339 — The NOxBOXi Nitric Oxide Delivery System
- K171696 — NOxBOXi Nitric Oxide Delivery System
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.
Reason for recall
Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.
Data sourced from openFDA. This site is unofficial and independent of the FDA.