Steris HexaVue Focus Integration System
HexaVue Focus Integration System may mismatch patient information on manually printed images, causing documentation discrepancies.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Steris Corporation began a recall of the HexaVue Focus Integration System, Software Version 2.0.18, on September 23, 2026. The recall involves 58 systems. A software issue may result in unintended mismatch of patient information on manually printed images, which could create a documentation discrepancy or incorrect association of clinical images with a patient record. The FDA added the recall to its Enforcement Report on October 7, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI matches.
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
- UDI-DI
- 00724995245047
Details
- Company began the recall
- Event ID
- 99856
- Company
- Steris Corporation
- Hazard
- Software defect
- Quantity recalled
- 58 systems
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
