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Z-1361-2026Class II

Steris Corporation

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Steris Corporation
Product type
Device
Status
Ongoing
Report date
2026-02-18
Distribution
US Nationwide distribution in the states of FL, NC, NY, OH, TN, TX, and VA.
Firm state
OH
Product quantity
10 units
Initiated by
Voluntary: Firm initiated
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.

Product description

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

Code / lot info

UDI-DI: 00724995220570; Serial Numbers for MNAs: 2531542441, 2531542470, 2531543549, 2531543611, 2531572419, 2531572433, 2531572440, 2531588558, 2531593768, and 2531595829

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →