FDA recall Z-1361-2026

Steris Corporation · Class II · device

Product

Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H

Reason for recall

This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used.

Distribution

US Nationwide distribution in the states of FL, NC, NY, OH, TN, TX, and VA.

Key facts

Status: Ongoing
Initiation date: 2025-05-23
Report date: 2026-02-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mentor, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1361-2026