Recall Z-1361-2026— Steris Corporation

Name: FDA recall Z-1361-2026
Creator: U.S. Food and Drug Administration
Published: 2025-05-23

Class II · Ongoing

Class II FDA medical device recall by Steris Corporation, initiated 2025-05-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H. Reason: 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..

Recalling firm: Steris Corporation
Classification: Class II
Status: Ongoing
Initiated: 2025-05-23
Firm location: Mentor, OH, United States

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.