FDA-Device2026-02-18Class IIPROCESSING DEFECT
Steris Barco MNA-6x0-H adapter recalled for incorrect configuration
What this means
Steris Corporation identified that a limited batch of MNA-6x0 adapter components used in the Barco MNA with HexaVue IP Integration System were manufactured with an incorrect configuration file. This affects 10 units with specific serial numbers distributed across seven states.
- Check if your device serial number matches the affected list (2531542441, 2531542470, 2531543549, 2531543611, 2531572419, 2531572433, 2531572440, 2531588558, 2531593768, 2531595829)
- Contact Steris Corporation if your device is affected to determine next steps
- Do not discard or alter the device without instructions from Steris
The agency's original wording
Hazard
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.
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of FL, NC, NY, OH, TN, TX, and VA.
Affected count
10 units
Manufactured in
5960 Heisley Rd, N/A, Mentor, OH, United States
Products
Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1361-2026Want us to check the next one for you?
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