Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended for use in the cleaning and…
Medical device recall Z-0876-2021. Published in FDA’s Enforcement Report on Jan 27, 2021.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 27, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 3405 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
3405, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial numbers: 361419028 3604919028 3610519017 3617619013 3625814030 3631216024 3600311010 3605009010 3610519018 3617619014 3625814031 3631216027 3600312001 3605010015 3610519019 3617619015 3625910009 3631216028 3600312004 3605018022…
Every code shown here, 1,995 characters
Serial numbers: 361419028 3604919028 3610519017 3617619013 3625814030 3631216024 3600311010 3605009010 3610519018 3617619014 3625814031 3631216027 3600312001 3605010015 3610519019 3617619015 3625910009 3631216028 3600312004 3605018022 3610519020 3617619016 3625913019 3631216029 3600312017 3605018023 3610520002 3617717009 3625913020 3631309006 3600312018 3605018024 3610520003 3617717010 3625913021 3631310001 3600317007 3605018025 3610520004 3617717011 3625913022 3631311001 3600317008 3605018026 3610520005 3617717020 3625913023 3631311002 3600317015 3605018027 3610618018 3617717021 3625913024 3631315020 3600317016 3605112002 3610618019 3617718012 3625913025 3631315021 3600317017 3605112003 3610618025 3617718013 3625913026 3631315022 3600317018 3605112026 3610618026 3617718014 3625913027 3631315023 3600317019 3605112027 3610618031 3617718015 3625913028 3631315024 3600318002 3605112029 3610709001 3617718016 3625916002 3631315025 3600318004 3605112030 3610712001 3617811002 3625916003 3631315026 3600410012 3605112031 3610712007 3617812005 3625919018 3631315028 3600416017 3605112032 3610811005 3617910002 3625919019 3631315029 3600416018 3605117015 3610817017 3617911003 3625919020 3631411004 3600416019 3605117016 3610817018 3617916011 3625919021 3631414017 3600416020 3605117020 3610817019 3617916012 3625919022 3631414018 3600416022 3605117021 3610817020 3617916013 3625919023 3631414021 3600416023 3605117022 3610910003 3618009007 3625919024 3631414022 3600419027 3605117023 3610911013 3618010002 3625919025 3631414023 3600419028 3605117024 3610916001 3618011001 3625919027 3631509007 3600419029 3605117025 3610916002 3618015007 3625919028 3631510001 3600510010 3605117026 3610916021 3618015013 3625919030 3631513033 3600511006 3605117027 3610916023 3618015014 3625919031 3631513034 3600511007 3605117028 3611015001 3618015021 3626009010 3631513035 3600515004 3605211013 3611015002 3618015022 3626010004 3631513036 3600515005 3605310006 3611109001 3618015023 3626010005 3631513037…
FDA’s list runs to 37,524 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 11, 2020.
- FDA classified it on Jan 15, 2021.
- FDA’s Enforcement Report published it on Jan 27, 2021.
- FDA terminated it on Jun 21, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Steris Corporation, of Mentor, OH.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 37,524 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.