FDA recall Z-3165-2026

Product

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.

Distribution

US Nationwide distribution in the state of Georgia.

Key facts

Status

Ongoing

Initiation date

2026-08-19

Report date

2026-09-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sittingbourne, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3165-2026