Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product Usage: The Reliance…
Medical device recall Z-2392-2018. Published in FDA’s Enforcement Report on Jul 18, 2018.
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 Jul 18, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 29 states named
- 118 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 has become aware that the Reliance 1227 Cart and Utensil Washer/Disinfector s Chemical Low Level alarm, intended to prevent the user from initiating a cycle when a low chemical level situation occurs, does not operate as intended. Currently, if a low chemical level situation occurs, the alarm will only be generated at the unit s next power-up or when accessing service mode. The failure of the Reliance 1227 to identify that the chemicals used for cleaning are low or empty could result in bedpans and urinals, basins, case carts, beds, theater shoes and other miscellaneous reusable patient care items not being properly cleaned before disinfection or reuse.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theatre shoes and other miscellaneous reusable items used in the care of patients.
118, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
3632511020 3634311005 3607312011 3615312001 3611012005 3627012001 3626212001 3633112020 3632612001 3601413013 3629612014 3602113013 3605113001 3615912011 3606613001A 3607413001 3612713001 3614913001 3616213001 3608613001 3623313001…
Every code shown here, 1,298 characters
3632511020 3634311005 3607312011 3615312001 3611012005 3627012001 3626212001 3633112020 3632612001 3601413013 3629612014 3602113013 3605113001 3615912011 3606613001A 3607413001 3612713001 3614913001 3616213001 3608613001 3623313001 3624113001 3626813001 3627313019 3628113001 3628213002 3629113001 3631613011 3635013015 3601514001 3603614001 3604114024 3604914002 3630113020 3613214010 3611814020 3616714023 3630813004 3628214010 3629414002 3630814002 3631614001 3631414016 3632914001 3632414003 3634914022 3604415042 3605415029 3606115033 3604715027 3608215021 3615215026 3613915001 3619415002 3623015006 3623715001 3627115035 3627315001 3627815020 3629215021 3629515001 3633015001 3632215001 3633615001 3634215001 3632315001 3626415043 3601116014 3602516001 3634315001 3604116001 3604616003 3604716001 3604816001 3606916011 3613716013 3618716001 3600616001 3625616008 3630116001 3632616007 3634216002 3633316017 3635416008 3625716001 3635616001 3603217002 3632116001 3635016001 3604517001 3604617001 3605417001 3606117001 3628616001 3605317001 3605117029 3607417001 3611417015 3612217002 3610917001 3611617001 3613617001 3613717001 3619817008 3619117006 3619917001 3619317001 3617717005 3630317038 3634117001 3601118001 3634517031 3606418014 3606518001 3608718001 3609318016 3610118001 3616814019
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 in the states of AL, AK, CA, CO, CN, DE, FL, GA, IL, IA, KS, KY, LA, MA, MI, NJ, NY, ND, OH, OK, OR, PA, RI, SC, TN, TX, VT, VA, WI, and WV. Foreign distribution to Canada.
The states and territories these words name
29 states and territories.
Every one of them
- Alaska
- Alabama
- California
- Colorado
- Delaware
- Florida
- Georgia
- Iowa
- Illinois
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Michigan
- North Dakota
- New Jersey
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- Tennessee
- Texas
- Virginia
- Vermont
- Wisconsin
- West Virginia
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 May 23, 2018.
- FDA classified it on Jul 9, 2018.
- FDA’s Enforcement Report published it on Jul 18, 2018.
- FDA terminated it on Nov 5, 2019.
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.”
- 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
-
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.