PENTAX Medical EC38-i20cLRecalls & reported problems
Hoya Corporation · PENTAX Medical Video Colonoscope EC38-i20cL · Class 2
All models of PENTAX Medical (34)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Pentax Medical video colonoscope is a flexible scope used to view the colon. Its 182 reports include no deaths and 2 injuries. Many describe fluid or blood leaking into the scope, a blocked lens, and no image on screen. There is 1 open recall, started in January 2025, over reddish or dark images and a tip that can get hot during use.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 185
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 185 adverse event reports that list this exact device (DI 04961333252169), received between Sep 18, 2023 and Sep 30, 2026 — classified as 2 injuries, 183 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (53 reports).
1 FDA recall record name this device's identifier, 1 still open.
3 other recalls cover devices cleared under the same FDA submission (K231249); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Jan 29, 2025Class IIOpen, Classified
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.
Z-1236-2025 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak53
- Optical Obstruction41
- No Display/Image38
- Erratic or Intermittent Display15
- Obstruction of Flow11
- Poor Quality Image9
- Break5
- Material Split, Cut or Torn5
Patient problems
- No Clinical Signs, Symptoms or Conditions183
- Foreign Body In Patient2
- Gastrointestinal Hemorrhage1
Recent adverse event reports
The 25 most recent of 185 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Erratic or Intermittent Display
The time of event is unknown.There was no report of patient harm.Video image failure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942343 ↗MalfunctionSep 29, 2026Material Split, Cut or Torn
The time of event is unknown.There was no report of patient harm.Insertion flexible tube (IFT) Steel braid piercing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927543 ↗MalfunctionSep 25, 2026No Display/Image
The time of event is unknown.There was no report of patient harm.Video image (Blackout).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893568 ↗MalfunctionSep 24, 2026No Display/Image
The time of event is unknown.There was no report of patient harm.Video image failure (Blackout).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877471 ↗MalfunctionSep 14, 2026Optical Obstruction
The time of event is unknown.There was no report of patient harm.Video image failure(Shadow in image).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749376 ↗MalfunctionSep 8, 2026Optical Obstruction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50661471 ↗MalfunctionSep 2, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50558337 ↗MalfunctionAug 28, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50490853 ↗MalfunctionAug 28, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50490847 ↗MalfunctionAug 18, 2026Optical Obstruction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50292699 ↗MalfunctionAug 17, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50269334 ↗MalfunctionAug 13, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50232156 ↗MalfunctionAug 12, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50217984 ↗MalfunctionAug 12, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50217977 ↗MalfunctionAug 3, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50111527 ↗MalfunctionAug 3, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50111519 ↗MalfunctionAug 3, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50111517 ↗MalfunctionJul 30, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50079010 ↗MalfunctionJul 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50064965 ↗MalfunctionJul 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50064958 ↗MalfunctionJul 28, 2026Optical Obstruction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50049586 ↗MalfunctionJul 21, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25884947 ↗MalfunctionJul 21, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25884937 ↗MalfunctionJul 15, 2026Optical Obstruction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25822219 ↗MalfunctionJul 15, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25822214 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K231249. One submission often covers many models, so check the product and lot details in each record.
- Z-2329-2025 · Jul 16, 2025 · Open, ClassifiedPentax Medical Video Processor; Model Number: EPK-i8020c;
- Z-1238-2025 · Jan 29, 2025 · Open, ClassifiedPentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation
- Z-1237-2025 · Jan 29, 2025 · Open, ClassifiedPENTAX 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
Other Endoscope, Accessories, Image Post-Processing For Color Enhancement devices
- PENTAX Medical EG29-i20cHoya Corporation · Endoscope, Accessories, Image Post-Processing For Color Enhancement1 recall123 reports
- INSPIRA EPK-i8020cHoya Corporation · Endoscope, accessories, image post-processing for color enhancement2 recalls24 reports
- OPTIVISTA EPK-i7010Hoya Corporation · Endoscope, accessories, image post-processing for color enhancement53 reports
- IMAGINA EPK-i5500cHoya Corporation · Endoscope, accessories, image post-processing for color enhancement30 reports
- DEFINA EPK-3000-USPentax Of America, Inc. · Endoscope, Accessories, Image Post-Processing For Color Enhancement9 reports
- VIDEO PROCESSOR EPK-I7010Pentax Of America, Inc. · Endoscope, Accessories, Image Post-Processing For Color Enhancement8 reports
- VIDEO PROCESSOR EPK-3000Pentax Of America, Inc. · Endoscope, Accessories, Image Post-Processing For Color Enhancement3 reports
- OPTIVISTA EPK-i7010Hoya Corporation · Endoscope, accessories, image post-processing for color enhancement3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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