Olympus Endoscopic Flushing Pump
Medical device recall Z-0329-2014. Published in FDA’s Enforcement Report on Nov 27, 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 Nov 27, 2013. 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
- 263 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?
There is a possibility that the pump head was not shipped in the locked position. If the pump head is in an unlocked position this may, under certain circumstances, cause the pump to stop and go into power stand-by mode.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tissues to remove blood, feces and other organic matter during endoscopic procedures.
263, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model OPF-2 with serial numbers: 21301567 21301799 21220870 21220876 21220878 21220869 21301569 21220788 21220710 21220712 21220181 21220707 21301315 21301216 21301672 21301675 21301793 21301795 21301960 21303157 21303159 21303161 21303388…
Every code shown here, 1,995 characters
Model OPF-2 with serial numbers: 21301567 21301799 21220870 21220876 21220878 21220869 21301569 21220788 21220710 21220712 21220181 21220707 21301315 21301216 21301672 21301675 21301793 21301795 21301960 21303157 21303159 21303161 21303388 21303390 21303391 21301064 21221126 21301053 21301059 21301570 21301573 21301054 21220701 21301066 21301203 21301205 21301209 21301673 21220706 21301572 21301052 21301055 21301065 21301571 21220953 21302798 21302917 21302920 21302925 21303009 21303017 21301058 21301060 21301485 21301493 21301566 21301408 21301961 21301804 21221123 21301317 21301483 21301217 21301320 21301482 21301214 21220357 21301062 21220179 21220171 21220789 21301487 21301489 21303156 21220877 21301413 21220176 21220711 21302919 21301796 21301797 21301415 21301963 21220174 21220168 21220704 21301056 21220621 21301204 21301207 21301212 21301215 21301575 21301206 21301213 21301321 21301322 21301406 21301484 21301568 21220709 21301409 21301404 21303162 21220790 21302791 21301414 21301407 21220785 21301410 21301210 21301211 21303010 21303014 21301411 21301577 21301208 21302921 21302923 21303013 21303397 21301316 21220868 21220787 21302910 21302911 21302912 21302915 21302918 21302974 21303012 21302913 21302922 21302924 21302973 21303008 21303015 21301490 21301492 21221124 21301957 21301959 21301965 21301966 21301967 21301968 21220169 21220951 21220963 21301313 21303016 21301798 21301486 21301488 21301491 21220615 21220618 21220625 21221125 21302914 21220871 21220880 21301405 21221122 21220175 21302916 21303158 21303160 21303387 21303392 21303393 21303396 21303398 21220180 21220708 21301674 21220702 21220616 21220623 21220783 21220793 21220178 21220613 21220620 21301962 21220865 21301958 21220260 21302971 21303389 21301061 21220872 21220875 21220879 21220952 21220954 21220955 21220956 21220957 21220958 21220959 21220960 21220961 21220962 21220964 21220965 21302792 21220172 21220866 21302972 21303011 21301794 21301800 21301802 21301803 21301319 21301412 21301574…
FDA’s list runs to 2,174 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: USA (nationwide) and the country of Canada.
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 20, 2013.
- FDA classified it on Nov 15, 2013.
- FDA’s Enforcement Report published it on Nov 27, 2013.
- FDA terminated it on Oct 24, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Olympus America Inc., of Center Valley, PA.
- 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 2,174 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.