PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and…
Medical device recall Z-1236-2025. 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
- 152 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 Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EC38-i20cL
152 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI: 04961333252169 Serial Numbers: A002FA0230 A002FA0244 A002FA0246 A002FA0247 A002FA0248 A002FA0259 A002FA0269 A002FA0271 A002FA0272 A002FA0274 A002FA0275 A002FA0278 A002FA0281 A002FA0282 A002FA0283 A002FA0293 A002FA0294 A002FA0299…
Every code shown here, 1,707 characters
UDI: 04961333252169 Serial Numbers: A002FA0230 A002FA0244 A002FA0246 A002FA0247 A002FA0248 A002FA0259 A002FA0269 A002FA0271 A002FA0272 A002FA0274 A002FA0275 A002FA0278 A002FA0281 A002FA0282 A002FA0283 A002FA0293 A002FA0294 A002FA0299 A002FA0300 A002FA0301 A002FA0303 A002FA0304 A002FA0306 A002FA0307 A002FA0311 A002FA0314 A002FA0315 A002FA0316 A002FA0321 A002FA0324 A002FA0364 A002FA0371 A002FA0372 A002FA0376 A002FA0378 A002FA0381 A002FA0383 A002FA0384 A002FA0388 A002FA0390 A002FA0399 A002FA0408 A002FA0415 A002FA0418 A002FA0419 A002FA0420 A002FA0422 A002FA0423 A002FA0424 A002FA0428 A002FA0432 A002FA0433 A002FA0435 A002FA0436 A002FA0437 A002FA0438 A002FA0439 A002FA0440 A002FA0443 A002FA0445 A002FA0446 A002FA0460 A002FA0462 A002FA0466 A002FA0474 A002FA0476 A002FA0477 A002FA0479 A002FA0485 A002FA0486 A002FA0487 A002FA0491 A002FA0492 A002FA0493 A002FA0496 A002FA0497 A002FA0505 A002FA0506 A002FA0514 A002FA0523 A002FA0539 A002FA0570 A002FA0578 A002FA0579 A002FA0580 A002FA0581 A002FA0592 A002FA0593 A002FA0594 A002FA0595 A002FA0596 A002FA0597 A002FA0604 A002FA0610 A002FA0611 A002FA0612 A002FA0613 A002FA0617 A002FA0619 A002FA0622 A002FA0633 A002FAA002 A002FAA005 A002FAA009 A002FAA010 A002FAA012 A002FAA017 A002FAA018 A002FAA021 A002FAA023 A002FAA024 A002FAA025 A002FAA026 A002FAA029 A002FAA030 A002FAA033 A002FAA034 A002FAA035 A002FAA036 A002FAA038 A002FAA051 A002FAA053 A002FAA056 A002FAA058 A002FAA065 A002FAA067 A002FAB002 A002FAB006 A002FAB018 A002FAB020 A002FAB024 A002FAB025 A002FAB026 A002FAB027 A002FAB029 A002FAB032 A002FAB048 A002FAB049 A002FAB050 A002FAB052 A002FAB053 A002FAB055 A002FAB057 A002FAB074 A002FAB076 A002FAB082 A002FAB084 A002FAB086 A002FAB097 A002FAB130 A002FAB132 A002FAB146
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.