Noxbox Ltd: Noxboxi Nitric Oxide Delivery System
Summary The NOxBOX NOxBOXi System, used to deliver inhaled nitric oxide therapy, is being recalled because it may leak oxygen during treatment. This affects patients who are currently using or have been prescribed this device. The recall was issued by NOxBOX.
- Recalling firm
- NOXBOX LTD
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-08-19
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the state of Georgia.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/01f94ab0-7fd9-4a80-bada-7e42b6d33f41