Food, drugs, devices › Steris Corporation
Device recall: Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended for use in the cleaning and intermediate lev
Steris Corporation (Mentor, OH) initiated this device recall on 11 Dec 2020; FDA lists 1 product record under event 86937, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 21 Jun 2022. Initiation: voluntary: firm initiated. Steris Corporation has 58 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Steris Corporation, Mentor, OH.
Reason for recall
"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."
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0876-2021 | 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… | 3405 | Class II | Terminated | 27 Jan 2021 |
Context
Other enforcement events for Steris Corporation
All 58 events for Steris Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Ecuador, France, Germany, Hong Kong, Ireland, Israel, Italy,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 21 Jun 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.