PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and…
Medical device recall Z-1237-2025. Published in FDA’s Enforcement Report on Mar 5, 2025.
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 Mar 5, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 138 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?
During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient’s mucous membranes.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EG29-i20c
138 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI: 04961333252145 Serial Numbers: A0038A0431 A0038A0433 A0038A0435 A0038A0447 A0038A0451 A0038A0452 A0038A0454 A0038A0458 A0038A0460 A0038A0474 A0038A0475 A0038A0479 A0038A0486 A0038A0488 A0038A0489 A0038A0492 A0038A0494 A0038A0496…
Every code shown here, 1,553 characters
UDI: 04961333252145 Serial Numbers: A0038A0431 A0038A0433 A0038A0435 A0038A0447 A0038A0451 A0038A0452 A0038A0454 A0038A0458 A0038A0460 A0038A0474 A0038A0475 A0038A0479 A0038A0486 A0038A0488 A0038A0489 A0038A0492 A0038A0494 A0038A0496 A0038A0497 A0038A0500 A0038A0502 A0038A0503 A0038A0507 A0038A0513 A0038A0514 A0038A0516 A0038A0527 A0038A0529 A0038A0536 A0038A0538 A0038A0539 A0038A0541 A0038A0557 A0038A0558 A0038A0560 A0038A0563 A0038A0566 A0038A0568 A0038A0570 A0038A0573 A0038A0574 A0038A0575 A0038A0577 A0038A0579 A0038A0583 A0038A0584 A0038A0585 A0038A0594 A0038A0595 A0038A0596 A0038A0597 A0038A0598 A0038A0599 A0038A0600 A0038A0601 A0038A0602 A0038A0605 A0038A0606 A0038A0607 A0038A0608 A0038A0609 A0038A0610 A0038A0613 A0038A0615 A0038A0616 A0038A0617 A0038A0618 A0038A0619 A0038A0621 A0038A0622 A0038A0623 A0038A0624 A0038A0625 A0038A0630 A0038A0636 A0038A0638 A0038A0639 A0038A0640 A0038A0644 A0038A0645 A0038A0646 A0038A0647 A0038A0648 A0038A0654 A0038A0762 A0038A0786 A0038A0794 A0038AA005 A0038AA010 A0038AA022 A0038AA030 A0038AA039 A0038AA057 A0038AA066 A0038AA067 A0038AA069 A0038AB005 A0038AB008 A0038AB012 A0038AB022 A0038AB023 A0038AB024 A0038AB049 A0038AB055 A0038AB056 A0038AB060 A0038AB063 A0038AB084 A0038AB088 A0038AB124 A0038AB125 A0038AB129 A0038AB130 A0038AB131 A0038AB144 A0038AB152 A0038AB162 A0038AB163 A0038AB164 A0038AB168 A0038AB169 A0038AB170 A0038AB171 A0038AB172 A0038AB180 A0038AB181 A0038AB183 A0038AB184 A0038AB186 A0038AB188 A0038AB189 A0038AB193 A0038AB194 A0038AB195 A0038AB197 A0038AB198 A0038AB200 A0038AB205
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
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Jan 29, 2025.
- FDA classified it on Feb 26, 2025.
- FDA’s Enforcement Report published it on Mar 5, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Pentax of America Inc, 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.”
- 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.