Z-1361-2026Class II

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

Name: Z-1361-2026 Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
Creator: Steris Corporation
Published: 2025-05-23
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2025-05-23 / Open, Classified / root cause: manufacturing process

FDA source

Steris Corporation began a recall of Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H on 2025-05-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1361-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-23
Posted: 2026-02-12
Recalling firm: STERIS Corporation
Product: Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
Product code: KQM Camera, Surgical And Accessories
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: All affected Customers have been contacted by a STERIS Service Technician arranging an onsite inspection of their unit(s) to locate and replace the affected MNA(s). Users are reminded to report any adverse events via FDA s MedWatch Database should an event occur. We apologize for any inconvenience this matter may cause, and as always, STERIS is dedicated to supporting our products and valued Customers. If you have questions regarding this matter, please contact Diksha Chechi, Quality Manager at 510-439-4500.
Quantity in commerce: 10 units
Distribution: US Nationwide distribution in the states of FL, NC, NY, OH, TN, TX, and VA.
Product codes and lots: UDI-DI: 00724995220570; Serial Numbers for MNAs: 2531542441, 2531542470, 2531543549, 2531543611, 2531572419, 2531572433, 2531572440, 2531588558, 2531593768, and 2531595829

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1361-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1361-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-12

Product code KQM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)