Steris Corporation Recalls Barco MNA with HexaVue IP Integration System Due to Configuration Error
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Steris Corporation is recalling 10 units of the Barco MNA with HexaVue IP Integration System after discovering that an incorrect configuration file was used during manufacturing.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references Florida, North Carolina, New York, Ohio, Tennessee, Texas, and Virginia. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Steris Corporation has initiated a voluntary Class II recall of the Barco MNA with the HexaVue IP Integration System. The recall was triggered after the supplier identified that an incorrect configuration file was used during the manufacturing process for a limited batch of MNA-6x0 (adapter) components. This action is a sub-recall of event RES 96885.
Which Products Are Affected
The recall involves the Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H.
A total of 10 units are affected, identified by the following serial numbers:
- 2531542441
- 2531542470
- 2531543549
- 2531543611
- 2531572419
- 2531572433
- 2531572440
- 2531588558
- 2531593768
- 2531595829
The UDI-DI for these products is 00724995220570. The affected units were distributed in Florida, North Carolina, New York, Ohio, Tennessee, Texas, and Virginia.
What You Should Do
Steris Corporation notified affected customers via a formal letter. Facilities in possession of the specific serial numbers listed above should follow the instructions provided in the firm's notification regarding the resolution of the configuration error. For further inquiries, customers should contact Steris Corporation at their Mentor, Ohio headquarters.
Why This Matters
This recall addresses a manufacturing defect in medical device components that could lead to improper system configuration. Ensuring the correct software and configuration files are present is critical for the reliable operation of IP integration systems in medical environments.
Source
Original source: FDA Official Notice ↗
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