EVOTECH Endoscope Cleaner and Reprocessor System 208V
Medical device recall Z-0965-2017. Published in FDA’s Enforcement Report on Jan 18, 2017.
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 Jan 18, 2017. 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
- 107 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 System because the hose may come loose and cause a leak.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high level disinfection of heat sensitive (>60¿C} semi-critical endoscopes.
107 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI 10705037030958 Serial No. 5041150187 UDI 10705037030958 Serial No. 5041150188 UDI 10705037030958 Serial No. 5041150189 UDI 10705037030958 Serial No. 5041150192 UDI 10705037030958 Serial No. 5041150191 UDI 10705037030958 Serial No.…
Every code shown here, 1,997 characters
UDI 10705037030958 Serial No. 5041150187 UDI 10705037030958 Serial No. 5041150188 UDI 10705037030958 Serial No. 5041150189 UDI 10705037030958 Serial No. 5041150192 UDI 10705037030958 Serial No. 5041150191 UDI 10705037030958 Serial No. 5041150190 UDI 10705037030958 Serial No. 5041150193 UDI 10705037030958 Serial No. 5041150205 UDI 10705037030958 Serial No. 5041150212 UDI 10705037030958 Serial No. 5041150207 UDI 10705037030958 Serial No. 5041150213 UDI 10705037030958 Serial No. 5041150206 UDI 10705037030958 Serial No. 5041150204 UDI 10705037030958 Serial No. 5041150210 UDI 10705037030958 Serial No. 5041150198 UDI 10705037030958 Serial No. 5041150228 UDI 10705037030958 Serial No. 5041150230 UDI 10705037030958 Serial No. 5041150229 UDI 10705037030958 Serial No. 5041150227 UDI 10705037030958 Serial No. 5041150226 UDI 10705037030958 Serial No. 5041150209 UDI 10705037030958 Serial No. 5041150231 UDI 10705037030958 Serial No. 5041150197 UDI 10705037030958 Serial No. 5041150236 UDI 10705037030958 Serial No. 5041150211 UDI 10705037030958 Serial No. 5041150235 UDI 10705037030958 Serial No. 5041150233 UDI 10705037030958 Serial No. 5041150234 UDI 10705037030958 Serial No. 5041150232 UDI 10705037030958 Serial No. 5041150196 UDI 10705037030958 Serial No. 5041150195 UDI 10705037030958 Serial No. 5041150199 UDI 10705037030958 Serial No. 5041150194 UDI 10705037030958 Serial No. 5041150202 UDI 10705037030958 Serial No. 5041150245 UDI 10705037030958 Serial No.5041150248 UDI 10705037030958 Serial No. 5041150246 UDI 10705037030958 Serial No. 5041150241 UDI 10705037030958 Serial No. 5041150247 UDI 10705037030958 Serial No. 5041150240 UDI 10705037030958 Serial No. 5041150242 UDI 10705037030958 Serial No. 5041150208 UDI 10705037030958 Serial No. 5041150239 UDI 10705037030958 Serial No. 5041150238 UDI 10705037030958 Serial No. 5041150237 UDI 10705037030958 Serial No. 5041150203 UDI 10705037030958 Serial No. 5041150200 UDI 10705037030958 Serial No. 5041150201 UDI 10705037030958 Serial No.…
FDA’s list runs to 4,303 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.
US Nationwide Distribution.
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.
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 Sep 27, 2016.
- FDA classified it on Jan 9, 2017.
- FDA’s Enforcement Report published it on Jan 18, 2017.
- FDA terminated it on Apr 17, 2017.
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 4,303 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.