Drug recall
HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing…
FDA recall event 99856 · Class II · Steris Corporation
Key facts
| Event ID | 99856 |
|---|---|
| Recall numbers | Z-0118-2027 |
| Recalling firm | Steris Corporation |
| Product type | Devices |
| Products | 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 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Sep 23, 2026 |
| Report date | Oct 14, 2026 |
| City | Mentor |
| State | OH |
| Country | United States |
| FEI number | 1527821 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: