Class II — Steris Corporation
| Recalling firm | STERIS Corporation |
|---|---|
| Registered facility | Key Surgical, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The electrical contactor component present in the drying chamber of the Reliance Vision Single-Chamber Washer/Disinfector may malfunction, potentially leading to the heating elements in the drying chamber to overheat, eventually resulting in smoke and/or fire. |
| Product | Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid surgical instruments, such as forceps and clamps, theatre shoes, and other similar and related articles found in healthcare facilities. |
| Quantity | 3405 |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Ecuador, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Republic of Malaysia, Mexico, New Zealand, Panama, Portugal, Russian Federation, Saudi Arabia, Singapore, Spain, Switzerland, Taiwan, United Arab Emirates, United Kingdom, Venezuela. |
| Initiated | 2020-12-11 |
| Classified | 2021-01-15 |
| Terminated | 2022-06-21 |
| Recall number | Z-0876-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Steris Corporation (Z-0876-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86937/
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