Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
Summary
The FDA issued a Class II for Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0- by Steris Corporation. 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) comp.
Details
Source
Device Recall
External ID
Z-1361-2026
Action Date
2026-02-18
Status
Ongoing
Category
device
Product Description
Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
Lot/Code Info: UDI-DI: 00724995220570; Serial Numbers for MNAs: 2531542441, 2531542470, 2531543549, 2531543611, 2531572419, 2531572433, 2531572440, 2531588558, 2531593768, and 2531595829
Quantity Affected: 10 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-23
Company
Mentor, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 200 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Steris Corporation has 71 FDA actions in our database, including 28 recalls and 43 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Steris Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Steris Corporation have FDA actions?
Steris Corporation has 71 FDA actions in our database, including 28 recalls and 43 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1361-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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