Recall Z-0029-2026— NOXBOX LTD
Class I · Ongoing
Class I FDA medical device recall by NOXBOX LTD, initiated 2025-09-09. It names 5 FDA 510(k) clearances: K233251, K231823, K220898 and 2 more. Product: NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I. Reason: The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts..
- Recalling firm
- NOXBOX LTD
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2025-09-09
- 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 Numbers: NOXBOX-I
Reason for recall
The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts.
Data sourced from openFDA. This site is unofficial and independent of the FDA.