EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004
Medical device recall Z-1714-2015. Published in FDA’s Enforcement Report on Jun 17, 2015.
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 17, 2015. 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
- 825 units 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?
Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because it may not detect an improper endoscope connection on two channels, and subsequently pass the cycle without cancellation if there is a disconnected scope.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to achieve cleaning and high level disinfection of heat sensitive (>60 ¿C) semi-critical endoscopes.
825 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
5040107065 5040107073 5040107104 5040107105 5040107106 5040107109 5040107111 5040107112 5040107114 5040107115 5040107121 5041070036 5041070037 5041070038 5041070039 5041070043 5041070044 5041070045 5041070048 5041080013 5041080014…
Every code shown here, 1,991 characters
5040107065 5040107073 5040107104 5040107105 5040107106 5040107109 5040107111 5040107112 5040107114 5040107115 5040107121 5041070036 5041070037 5041070038 5041070039 5041070043 5041070044 5041070045 5041070048 5041080013 5041080014 5041080020 5041080057 5041080059 5041080061 5041080062 5041080065 5041080066 5041080068 5041080069 5041080070 5041080071 5041080072 5041080073 5041080074 5041080077 5041090022 5041090023 5041090024 5041090028 5041090031 5041090034 5041090053 5041090054 5041090056 5041090057 5041090058 5041090060 5041090062 5041090064 5041090065 5041090066 5041090067 5041090068 5041090069 5041090070 5041090086 5041090087 5041090090 5041090092 5041090093 5041090096 5041090098 5041090099 5041090100 5041090103 5041090104 5041090105 5041090106 5041090107 5041090108 5041090109 5041090110 5041090112 5041090113 5041090121 5041090122 5041090123 5041090124 5041090125 5041090126 5041090128 5041090130 5041090132 5041090133 5041090134 5041090135 5041090136 5041090137 5041090138 5041090139 5041090141 5041090142 5041090145 5041090147 5041090151 5041090153 5041090154 5041090155 5041090157 5041090159 5041090160 5041090164 5041090165 5041090167 5041090168 5041090169 5041090174 5041090176 5041090177 5041090178 5041090179 5041090180 5041090181 5041090182 5041090183 5041090184 5041090186 5041090187 5041090188 5041090189 5041090190 5041090193 5041090194 5041090203 5041090204 5041090206 5041090207 5041090209 5041090210 5041090214 5041090215 5041090216 5041090217 5041090218 5041090219 5041090220 5041090221 5041090222 5041100002 5041100003 5041100004 5041100005 5041100006 5041100007 5041100009 5041100010 5041100011 5041100012 5041100013 5041100015 5041100016 5041100017 5041100018 5041100019 5041100020 5041100021 5041100022 5041100023 5041100024 5041100025 5041100026 5041100028 5041100029 5041100030 5041100031 5041100032 5041100033 5041100034 5041100039 5041100041 5041100042 5041100043 5041100045 5041100046 5041100047 5041100048 5041100049 5041100050 5041100059 5041100060…
FDA’s list runs to 9,074 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) and the countries of Australia, Singapore, Canada, and Thailand.
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 May 11, 2015.
- FDA classified it on Jun 5, 2015.
- FDA’s Enforcement Report published it on Jun 17, 2015.
- FDA terminated it on Jul 6, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Advanced Sterilization Products, of Irvine, CA.
- 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 9,074 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.