# Class II recall Z-0118-2027: Steris Corporation

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0118-2027 |
| Recalling firm | Steris Corporation |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| 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 |
| 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. |
| Quantity | 58 systems |
| Distribution | Worldwide - US Nationwide and the countries of Australia, Canada, New Zealand. |
| Recall initiated | 2026-09-23 |
| Reported | 2026-10-14 |
| Firm location | Mentor, OH, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 22 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0118-2027%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.