CLASS II ONGOING Device recall · Reported 18 Feb 2026 · FDA Enforcement Report

Barco MNA with the HexaVue IP Integration System recalled by Steris

Steris is recalling Barco MNA with the HexaVue IP Integration System, distributed nationwide in the US. The recall was initiated on 23 May 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 00724995220570; Serial Numbers for MNAs: 2531542441, 2531542470, 2531543549, 2531543611, 2531572419, 2531572433, 2531572440, 2531588558, 2531593768, and 2531595829

Quantity recalled10 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1361-2026
FDA event ID: 98266
Recalling firm: Steris, Mentor, OH
Classification: Class II
Status: Ongoing
Recall initiated: 23 May 2025
FDA classified: 12 Feb 2026
Reported: 18 Feb 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

23 May 2025	Recall initiated by company
12 Feb 2026	Classified by FDA	+265 days
18 Feb 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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 as listed by the FDA

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

Where it was distributed

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

Nationwide Florida North Carolina New York Ohio Tennessee Texas Virginia

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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