EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video…
Medical device recall Z-2116-2014. Published in FDA’s Enforcement Report on Jul 30, 2014.
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 Jul 30, 2014. 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
- 531 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?
Aspiration needles used in combination with Ultrasound Gastroscopes can derail from the accessory elevator at the distal end of the endoscope. This may result in patient injury if the Instruction for Use is not followed carefully by the user.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
531 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model: EG-3630U A01013 E010080 E110111 E110159 E110236 A01017 E010082 E110116 E110161 E110237 A01022 E010084 E110118 E110167 E110239 A01025 E010092 E110120 E110169 E110240 A01026 E010093 E110132 E110172 E110256 A01028 E010094 E110134…
Every code shown here, 1,997 characters
Model: EG-3630U A01013 E010080 E110111 E110159 E110236 A01017 E010082 E110116 E110161 E110237 A01022 E010084 E110118 E110167 E110239 A01025 E010092 E110120 E110169 E110240 A01026 E010093 E110132 E110172 E110256 A01028 E010094 E110134 E110177 E110277 A01029 E010095 E110135 E110179 E110278 A01031 E010096 E110138 E110182 E110282 A01033 E01037 E110139 E110187 E110283 A01036 E01038 E110140 E110188 E110285 E010064 E01039 E110141 E110193 E110287 E010066 E01042 E110144 E110195 E110289 E010069 E01043 E110145 E110202 E110290 E010070 E01046 E110146 E110205 E110306 E010075 E01054 E110147 E110208 E110307 E010077 E01061 E110156 E110210 E110308 E010078 E01062 E110157 E110219 Model: EG-3830UT E110067 E110160 E110204 E110275 E110374 E110070 E110163 E110206 E110277 E110377 E110074 E110165 E110212 E110286 E110379 E110079 E110168 E110214 E110289 E110426 E110082 E110171 E110224 E110292 E110428 E110093 E110172 E110228 E110295 E110433 E110095 E110174 E110230 E110309 E110439 E110108 E110183 E110243 E110310 E110442 E110126 E110186 E110255 E110323 E110444 E110142 E110189 E110263 E110331 E110454 E110152 E110195 E110265 E110340 E110517 E110153 E110196 E110268 E110341 Model: FG-36UX A01014 A01049 A01079 A01100 A01166 A01019 A01053 A01080 A01104 A01168 A01020 A01054 A01081 A01105 A01174 A01029 A01055 A01082 A01116 A01183 A01030 A01056 A01084 A01122 A01184 A01033 A01057 A01086 A01126 A01186 A01036 A01068 A01092 A01131 A110260 A01040 A01070 A01096 A01137 A110268 A01046 A01074 A01098 A01142 Model: EG-3870UTK A110013 A110060 A110095 A110125 A110154 A110021 A110061 A110096 A110126 A110155 A110022 A110062 A110098 A110127 A110156 A110024 A110063 A110099 A110128 A110161 A110025 A110065 A110100 A110129 A110162 A110026 A110067 A110101 A110130 A110163 A110028 A110068 A110104 A110133 A110164 A110029 A110069 A110105 A110134 A110165 A110031 A110070 A110106 A110135 A110166 A110033 A110071 A110107 A110138 A110167 A110038 A110073 A110108 A110139 A110168 A110040 A110076 A110110 A110140 A110169 A110041 A110077…
FDA’s list runs to 3,996 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 Jun 12, 2014.
- FDA classified it on Jul 24, 2014.
- FDA’s Enforcement Report published it on Jul 30, 2014.
- FDA terminated it on Nov 17, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Pentax Medical Company, of Montvale, NJ.
- 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 3,996 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.