FDA recall Z-2544-2025
NOXBOX LTD · Class II · device
Product
NOxBOXi Nitric Oxide Delivery System
Reason for recall
Replacement of the internal Sample Pump due to high failure rates.
Distribution
US Nationwide distribution in the state of TN.
Key facts
- Status
- Ongoing
- Initiation date
- 2023-07-19
- Report date
- 2025-09-17
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Sittingbourne, N/A, United Kingdom
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2544-2025