Class II — Steris Corporation
| Recalling firm | STERIS Corporation |
|---|---|
| Registered facility | Key Surgical, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | 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 |
| Quantity | 58 systems |
| Distribution | Worldwide - US Nationwide and the countries of Australia, Canada, New Zealand. |
| Initiated | 2026-09-23 |
| Classified | 2026-10-07 |
| Recall number | Z-0118-2027 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-29. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Steris Corporation (Z-0118-2027).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-29. https://regwarden.com/recall/99856/
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