Reliance Synergy Washer/Disinfector
Medical device recall Z-1256-2022. Published in FDA’s Enforcement Report on Jun 15, 2022.
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 Jun 15, 2022. 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
- 3,863 total units (2,776 US; 1,087 OUS) 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 firm identified that when the electrical contactor component in the drying chamber of the Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Reliance Synergy Washer/Disinfector
3,863 total units (2,776 US; 1,087 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: 00724995152161 Serial Numbers: 3633702001 3633702002 3633802007 3633702004 3633902002 3602303011 3602403002 3604403007 3605203010 3603003006 3603403007 3604403006 3633802008 3606503002 3606403002 3606403003 3606503001 3605103003…
Every code shown here, 1,999 characters
UDI-DI: 00724995152161 Serial Numbers: 3633702001 3633702002 3633802007 3633702004 3633902002 3602303011 3602403002 3604403007 3605203010 3603003006 3603403007 3604403006 3633802008 3606503002 3606403002 3606403003 3606503001 3605103003 3607303014 3605203011 3607303013 3633302004 3610703003 3610803004 3609203001 3609403001 3609003005 3633702005 3610803002 3612103005 3615703001 3615703002 3612203006 3612703013 3615303012 3602303013 3615003008 3604503002 3614003006 3618803002 3618803003 3614603009 3618203003 3620903009 3608503002 3614803010 3614803012 3614803011 3622403010 3622303020 3609003004 3609203002 3623703010 3621803008 3614603010 3614903008 3623703011 3623703012 3624503005 3620903011 3624503006 3628103009 3629303002 3629303005 3630203001 3630303002 3631703001 3628103008 3628103010 3621603009 3622603008 3622003002 3621703005 3626603004 3626903003 3626903004 3623703009 3623403010 3634903010 3628903010 3627603009 3605203009 3635003003 3635003004 3631803003 3632803004 3632803005 3632803006 3631803002 3635603008 3614003002 3614003002B 3635603010 3635703003 3601204005 3601304001 3601604002 3601604003 3603503002 3602604007 3604004006 3601204004 3601304004 3602104003 3602604005 3628103002A 3602904004 3603004002 3603704003 3626503007 3604304001 3604304002 3604404004 3605004003 3605604003 3602604006 3627503010 3605804005 3605604010 3605704006 3602004002 3600704003 3602004003 3602104002 3606104007 3606904004 3606904005 3606904002 3606904001 3606904003 3606804005 3607804003 3606904006 3607704004 3606404001 3606404002 3607604003 3607904009 3607004004 3606804006 3607704005 3603704004 3603704005 3604004005 3602704005 3628103002 3612504003 3612504002 3613504001 3609004005 3609804004 3610504003 3610504002 3607504008 3611404004 3610004010 3611904005 3616104010 3616304003 3611704006 3612404016 3612504004 3612704002 3613204004 3612804003 3613104004 3614104009 3610704004 3611704005 3612104007 3611104008 3604904004 3604904005 3602704004 3604004004 3604404005 3613304005 3613404007…
FDA’s list runs to 42,634 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.
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 Apr 22, 2022.
- FDA classified it on Jun 9, 2022.
- FDA’s Enforcement Report published it on Jun 15, 2022.
- FDA terminated it on Nov 4, 2024.
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 42,634 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.