Lower risk Medical device recall · FDA · Published May 23, 2025

Steris Barco MNA-6x0-H: Incorrect Configuration File Risk

Steris recalls Barco MNA-6x0-H models with incorrect configuration files from limited manufacturing batch. Affected units have specific serial numbers; contact Steris for remedy.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1361-2026Medical device Steris ›

Lower-risk 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.

Take action

Contact the company

Recalling firmSteris Corporation5960 Heisley Rd · Mentor, OH 44060-1834

✎ GovInfoNow plain-language explainer

Steris is recalling a limited batch of Barco MNA-6x0-H models due to an incorrect configuration file used during manufacturing. This could cause improper system operation but does not pose an immediate safety risk. Read more at govinfonow.com/recall/52224-steris-barco-mna-6x0-h-incorrect-configuration-file-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/52224-steris-barco-mna-6x0-h-incorrect-configuration-file-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1361-2026

Cite this page

“Steris Barco MNA-6x0-H: Incorrect Configuration File Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52224-steris-barco-mna-6x0-h-incorrect-configuration-file-risk. Based on FDA recall #Z-1361-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1361-2026%22&limit=1).

The FDA announced on May 23, 2025, that Steris Corporation is voluntarily recalling Barco MNA units with the HexaVue IP Integration System due to the use of an incorrect configuration file during manufacturing. The recall affects 10 units distributed nationwide and in specific states.

How to tell if you have it

Brand: Steris
Product: Barco MNA with the HexaVue IP Integration System
Model/Catalog Number: MNA-6x0-H
UDI-DI: 00724995220570
Serial Numbers: 2531542441, 2531542470, 2531543549, 2531543611, 2531572419, 2531572433, 2531572440, 2531588558, 2531593768, and 2531595829
Distribution: US Nationwide, FL, NC, NY, OH, TN, TX, VA

The hazard

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

Context

GovInfoNow's records show Steris Corporation has 29 other recalls on record since June 15, 2017. On May 15, 2026, Steris issued recalls for potential paint delamination on lighting system light heads and detached buttons on HarmonyAIR A-Series Surgical Lights. Another recall on November 19, 2025, involved an electrical arcing risk in the Steris AMSCO 7052HP Washer/Disinfector.

How to tell if you have this one

Check if your Barco MNA-6x0-H has a serial number from the list: 2531542441, 2531542470, 2531543549, 2531543611, 2531572419, 2531572433, 2531572440, 2531588558, 2531593768, or 2531595829.

Brand
Steris
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Number
Verify your device's serial number against the list provided in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 7 states.

FDA distribution: “US Nationwide distribution in the states of FL, NC, NY, OH, TN, TX, and VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, New York, North Carolina, Ohio, Tennessee, Texas, Virginia.

Recall timeline

FDA published this recall 9 months after the firm started it.

May 23, 2025Firm started the recall
Feb 12, 2026FDA classified it Class II
Feb 18, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/52224-steris-barco-mna-6x0-h-incorrect-configuration-file-risk">Steris Barco MNA-6x0-H: Incorrect Configuration File Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1361-2026 (May 23, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1361-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.