Recall Z-0028-2026— 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: Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz)..
- 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
Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz).
Data sourced from openFDA. This site is unofficial and independent of the FDA.