Medium risk Medical DevicesClass II

Steris Corporation Recall

HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and env

Updated September 23, 2026

Steris Corporation is recalling HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and env. Hazard: A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a documentation discrepancy or incorrect association of clinical images with a patient record.

Is the Steris Corporation recalled? Yes. This product was recalled by FDA on September 23, 2026. Details below.

What is recalled

HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and environmental control, Software Version: 2.0.18

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

The hazard

A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a documentation discrepancy or incorrect association of clinical images with a patient record.

Brands affected

Source
FDA
Category
Medical Devices
Recall ID
fda-Z-0118-2027
Classification
Class II
Recalled
September 23, 2026
Read the official notice

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