EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean and high-level…
Medical device recall Z-1123-2013. Published in FDA’s Enforcement Report on Apr 24, 2013.
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 Apr 24, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 44 states named
- 273 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) has determined that a limited number of EVOTECH ECRs manufactured between 2011 and 2012 did not receive sufficient High Potential (HIPOT) DC voltage testing.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
273 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 5041110026 5041110070 5041110041 5041110082 5041110083 5041110076 5041110075 5041110078 5041110085 5041110092 5041110091 5041110077 5041110079 5041110086 5041110081 5041110084 5041110080 5041110087 5041110105 5041110099…
Every code shown here, 1,996 characters
Serial Numbers: 5041110026 5041110070 5041110041 5041110082 5041110083 5041110076 5041110075 5041110078 5041110085 5041110092 5041110091 5041110077 5041110079 5041110086 5041110081 5041110084 5041110080 5041110087 5041110105 5041110099 5041110104 5041110101 5041110088 5041110106 5041110090 5041110093 5041110110 5041110108 5041110115 5041110112 5041110116 5041110114 5041110107 5041110074 5041110102 5041110111 5041110113 5041110098 5041110100 5041110071 5041110073 5041110117 5041110123 5041110122 5041110124 5041110125 5041110126 5041110109 5041110127 5041110120 5041110129 5041110130 5041110134 5041110128 5041110135 5041110143 5041110136 5041110137 5041110121 5041110140 5041110132 5041110131 5041110144 5041110145 5041110141 5041110146 5041110133 5041110142 5041110147 5041110148 5041110150 5041110151 5041110152 5041110156 5041110149 5041110157 5041110153 5041110154 5041110155 5041110158 5041110159 5041110160 5041110161 5041110162 5041110171 5041110164 5041110172 5041110173 5041110175 5041110163 5041110176 5041110177 5041110179 5041110178 5041110180 5041110182 5041110185 5041110184 5041110183 5041110186 5041110187 5041110189 5041110190 5041110192 5041110174 5041110191 5041110194 5041110195 5041110196 5041110188 5041110199 5041110197 5041110198 5041110205 5041110200 5041110206 5041110203 5041110207 5041110208 5041110211 5041110210 5041110216 5041110209 5041110225 5041110220 5041110218 5041110227 5041110219 5041110229 5041110212 5041110215 5041110223 5041110224 5041110221 5041110214 5041110226 5041120061 5041120065 5041120057 5041120064 5041120059 5041120069 5041120063 5041120072 5041120074 5041120066 5041120068 5041120070 5041120073 5041120076 5041120078 5041120079 5041120075 5041120077 5041120080 5041120084 5041120092 5041120096 5041120094 5041120071 5041120086 5041120089 5041120090 5041120088 5041120093 5041120095 5041120098 5041120103 5041120101 5041120091 5041120097 5041120104 5041120062 5041120105 5041120099 5041120085 5041120102 5041120108 5041120060 5041120107…
FDA’s list runs to 3,018 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.
Nationwide Distribution-USA including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI.
The states and territories these words name
44 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
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.
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 Mar 22, 2013.
- FDA classified it on Apr 15, 2013.
- FDA’s Enforcement Report published it on Apr 24, 2013.
- FDA terminated it on Nov 18, 2013.
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 3,018 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.