Recall Z-3165-2026— NOXBOX LTD
Class II · Ongoing
Class II FDA medical device recall by NOXBOX LTD, initiated 2026-08-19. It names 5 FDA 510(k) clearances: K233251, K231823, K220898 and 2 more. Product: NOxBOXi Nitric Oxide Delivery System.. Reason: Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation..
- Recalling firm
- NOXBOX LTD
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-08-19
- Firm location
- Sittingbourne, N/A, 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.
Reason for recall
Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.
Data sourced from openFDA. This site is unofficial and independent of the FDA.