EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180
Medical device recall Z-2818-2015. Published in FDA’s Enforcement Report on Oct 7, 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 Oct 7, 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
- 1014 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?
Insufficient information for specific cleaning accessories used for the cleaning and reprocessing of the GF-UCT180 ultrasound endoscope
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.
1014, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Models: GF-UCT180 with serial numbers: 1110499 1210800 7410282 1310997 1311003 1311004 1310999 1311000 1210572 7310007 7310012 1210883 1310886 7510736 7510753 1110488 1110309 7410481 7410477 7310025 7510647 7510648 7510811 7510810 7510809…
Every code shown here, 1,999 characters
Models: GF-UCT180 with serial numbers: 1110499 1210800 7410282 1310997 1311003 1311004 1310999 1311000 1210572 7310007 7310012 1210883 1310886 7510736 7510753 1110488 1110309 7410481 7410477 7310025 7510647 7510648 7510811 7510810 7510809 7510832 7510830 7510827 7510704 7410530 7410524 7410526 7410525 7510734 7510726 7510688 1210542 7410289 1311015 1311016 7410335 1210874 7410426 1210687 7410546 7410145 7310031 1110477 1110479 1110497 1310945 1110511 1110482 7510569 7410353 1110397 1100203 1100198 1110457 1110504 7310026 1110500 7410206 7510766 1311022 1110503 1210836 1210876 1210748 7510560 7510561 7410285 1210632 1210644 7510654 7510730 7510678 1210692 1210695 1210643 7510724 7510725 1310991 7510731 1310944 7310055 7310059 1110374 1110509 7310039 7510798 7410230 1210611 1210615 1210617 1210610 1210612 1210604 1210602 7410173 7410171 7410168 7410167 7410165 1210737 1210733 1311186 1311190 7410545 7310033 7310038 7410252 1000144 1000164 7410218 7410221 7510639 7510641 7510649 1310890 1000156 1000157 7510844 1210827 1110336 1110307 7410220 1311096 1311103 7410337 1210855 7410338 1210773 7510758 7510761 7410260 7410270 1310969 7410344 1310983 7510705 1210878 7510646 7510676 7510729 7510675 7410515 7410508 1210872 7510685 1110370 1210766 7510643 7410185 1210619 1311079 1311151 1311037 7510619 7410184 7510792 1210805 1110478 7410336 7410267 1311007 7410305 1210530 1210543 7410536 1000162 7510681 1311058 7410235 1311189 1311042 1311044 7310061 1110431 7510564 7510562 1311157 1110408 7410308 1210571 7510803 7510805 7410466 7410460 7410283 7310096 7510768 1210757 7310045 7310051 7410243 1310917 1110506 1110440 7410435 7410433 7410434 7410424 7410427 7410428 1000171 1100175 7310064 7410326 7410328 7510745 7510584 1311139 1311081 1110489 1110513 1210818 1210875 7310028 7310030 7310056 7310057 7310063 7310071 7310079 7310077 7310080 7310081 1311033 7410231 1210667 1210689 1210801 1110433 1110434 7510682 7310017 7310019 7410367 1310955 1310964 1210578 1311127 7410416 7510721…
FDA’s list runs to 8,350 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
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 Aug 21, 2015.
- FDA classified it on Sep 28, 2015.
- FDA’s Enforcement Report published it on Oct 7, 2015.
- FDA terminated it on May 8, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Olympus Corporation of the Americas, 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 8,350 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
-
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.