Hearth Record

Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062

Medical device recall Z-1595-2023. Published in FDA’s Enforcement Report on May 24, 2023.

FDA’s own record, on accessdata.fda.gov

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 May 24, 2023. Copied from openFDA on Oct 20, 2026.

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

In the remote occurrence in which the electrical contactor component present in the drying chambers of the Reliance Vision Multi-Chamber Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062

322 units, in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

UDI-DI: 00724995193164; Serial Numbers: 3600416016 3604417032 3608519001 3616109004 3624018002 3629014002 3633013003 3600622024 3604520026 3608615002 3616111012 3624210004 3629108006 3633206001 3600714004 3604612002 3609014014 3616113019…

Every code shown here, 1,994 characters

UDI-DI: 00724995193164; Serial Numbers: 3600416016 3604417032 3608519001 3616109004 3624018002 3629014002 3633013003 3600622024 3604520026 3608615002 3616111012 3624210004 3629108006 3633206001 3600714004 3604612002 3609014014 3616113019 3624521001 3629112001A 3633317002 3600908001 3604710009 3609207002 3616318001 3624616022 3629119023 3633319035 3600908011 3605009011 3609422016 3616320002 3624812020 3629217002 3633321010 3601011012 3605013002 3609512007 3616914006 3624919019 3629420002 3633511005 3601014015 3605015001 3609809008A 3616918017 3625010007 3629711013 3633514038 3601017002 3605219005 3609814014 3617007001 3625114031 3629719006 3633515002 3601210008 3605312002 3609819030 3617009001 3625213015 3629921003 3633515004 3601215025 3605317002 3610007005 3617219002 3625220019 3630214002 3633520032 3601414005 3605411007 3610108008 3617310007 3625321002A 3630218043 3633609012 3601822001 3605510007 3610113001 3617414019 3625412018 3630320001 3633613033 3602108001 3605514027 3610312006 3617516021 3625518003 3630419006 3633707001 3602108005 3605715001 3610614003 3617520001 3625611009 3630511006 3633718036 3602110011 3605809011 3611115001 3618021027 3626009006 3630617003 3633813008 3602114001 3605814002 3611208008 3618407005 3626119006 3630618025 3634010002 3602213002 3606012003 3611222002 3618419005 3626120002 3630716003 3634019028 3602323012 3606110010 3611507014 3618506004 3626217001 3630921002 3634111014A 3602411012 3606111003 3611512001 3618517001 3626410001 3631006005A 3634116003 3602511011 3606117003 3611618001 3618709008 3626611005 3631019002 3634421001 3602512001 3606216001 3611709005 3618915003 3626621028 3631212002 3634608008A 3602517002 3606319035 3611717001 3618919003 3626719002 3631216030 3634707001 3602609007 3606414002 3611915001 3619020001 3626807001 3631217002 3634914028 3602714001 3606415003 3612318005 3619108006 3626912007 3631415002 3635313002 3602822001 3606416009 3613309009 3619312002A 3627210004 3631420028 3635820001 3602915001 3606712001…

FDA’s list runs to 3,632 characters. The first part is shown; the rest is on FDA’s record.

Source:

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) and OUS (Foreign) to countries of: China, Lithuania, Saudi Arabia, Korea, Republic of, Canada, Taiwan, United Kingdom, Spain, Australia, New Zealand, Spain, Brazil, Bahrain, Switzerland, Great Britain, South Africa, Hong Kong, Qatar.

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

Is it still going on?

Ongoing, in FDA’s file.

“A recall which is currently in progress.”

openFDA, on “On-Going”, its enforcement report fields.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on Apr 10, 2023.
  • FDA classified it on May 17, 2023.
  • FDA’s Enforcement Report published it on May 24, 2023.
Source:

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.
Source:

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 3,632 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.
Source:

Hearth Record wrote these lines; the quotations are FDA’s.

Sources

  • 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.

Source:

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.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

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Every fact names its source.

Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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