PENTAX MedicalRecalls & reported problems across all models
Hoya Corporation · 34 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one PENTAX Medical model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 6,159
- Deaths reported
- 2
- Injuries reported
- 124
- Recalls
- 2
We found 34 models of PENTAX Medical by Hoya Corporation in the FDA's device registry (GUDID). Together they are named in 6,159 adverse event reports in the FDA's MAUDE database, received between Mar 12, 2021 and Sep 30, 2026 — classified as 2 deaths, 124 injuries, 6,033 malfunctions.
The most frequently reported specific device problem is “Optical Obstruction” (1,459 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
PENTAX Medical recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 29, 2025Open, 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-1237-2025 · Root cause: Device Design · Recall details · FDA record ↗
- Jan 29, 2025Open, 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 PENTAX Medical problems
Device problems
- Optical Obstruction1,459
- Break1,257
- Fluid/Blood Leak995
- Erratic or Intermittent Display645
- No Display/Image499
- Optical Distortion396
- Obstruction of Flow395
- Detachment of Device or Device Component154
Patient problems
- No Clinical Signs, Symptoms or Conditions6,053
- Insufficient Information52
- Device Embedded In Tissue or Plaque40
- Foreign Body In Patient28
- Pain6
- Bacterial Infection4
- Hemorrhage/Blood Loss/Bleeding4
- Airway Obstruction3
PENTAX Medical models
34 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PENTAX Medical EG29-i10cGastroscope And Accessories, Flexible/Rigid1,623 reports
- PENTAX Medical EC38-i10cLColonoscope and accessories, flexible/rigid1,618 reports
- PENTAX Medical ED34-i10T2duodenoscope and accessories, flexible/rigid826 reports
- PENTAX Medical EC34-i10cLColonoscope and accessories, flexible/rigid571 reports
- PENTAX Medical EG38-J10UTEndoscopic Ultrasound System, Gastroenterology-Urology295 reports
- PENTAX Medical EC38-i20cLEndoscope, Accessories, Image Post-Processing For Color Enhancement1 recall185 reports
- PENTAX Medical EG29-i20cEndoscope, Accessories, Image Post-Processing For Color Enhancement1 recall123 reports
- PENTAX Medical EB19-J10UBRONCHOSCOPE (FLEXIBLE OR RIGID)130 reports
- PENTAX Medical EG36-J10UREndoscopic Ultrasound System, Gastroenterology-Urology126 reports
- PENTAX Medical EG34-i10Gastroscope And Accessories, Flexible/Rigid2 deaths104 reports
- PENTAX Medical EG29-i10cGastroscope And Accessories, Flexible/Rigid95 reports
- PENTAX Medical EC38-i10cLColonoscope and accessories, flexible/rigid82 reports
- PENTAX Medical EG34-J10UEndoscopic Ultrasound System, Gastroenterology-Urology61 reports
- PENTAX Medical EC34-i20cLGastroscope And Accessories, Flexible/Rigid51 reports
- PENTAX Medical EB19-J10BRONCHOSCOPE (FLEXIBLE OR RIGID)45 reports
- PENTAX Medical EC34-i10TLColonoscope and accessories, flexible/rigid35 reports
- PENTAX Medical EG17-J10Gastroscope and accessories, flexible/rigid35 reports
- PENTAX Medical OE-A63Duodenoscope And Accessories, Flexible/Rigid30 reports
- PENTAX Medical EB15-J10BRONCHOSCOPE (FLEXIBLE OR RIGID)20 reports
- PENTAX Medical VNL11-J10Nasopharyngoscope (Flexible Or Rigid)17 reports
- PENTAX Medical EC34-i10cLColonoscope and accessories, flexible/rigid16 reports
- PENTAX Medical VNL8-J10Nasopharyngoscope (Flexible Or Rigid)14 reports
- PENTAX Medical ED32-i10duodenoscope and accessories, flexible/rigid14 reports
- PENTAX Medical EG36-J10UREndoscopic Ultrasound System, Gastroenterology-Urology12 reports
- PENTAX Medical VNL11-J10Nasopharyngoscope (Flexible Or Rigid)8 reports
- PENTAX Medical VNL15-J10Nasopharyngoscope (Flexible Or Rigid)5 reports
- PENTAX Medical CS2022AAccessories, Cleaning Brushes, For Endoscope5 reports
- PENTAX Medical EB11-J10BRONCHOSCOPE (FLEXIBLE OR RIGID)4 reports
- PENTAX Medical EG34-J10UEndoscopic Ultrasound System, Gastroenterology-Urology3 reports
- PENTAX Medical EG27-i20cGastroscope And Accessories, Flexible/Rigid2 reports
- PENTAX Medical EPK-i5010Endoscope, accessories, image post-processing for color enhancement1 report
- PENTAX Medical VNL8-J10Nasopharyngoscope (Flexible Or Rigid)1 report
- PENTAX Medical EB11-J10BRONCHOSCOPE (FLEXIBLE OR RIGID)1 report
- PENTAX Medical ED34-i10T2sduodenoscope and accessories, flexible/rigid1 report
Recent PENTAX Medical adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 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 50942350 ↗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 50942346 ↗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 29, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927540 ↗MalfunctionSep 25, 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 50893626 ↗MalfunctionSep 25, 2026Fluid/Blood Leak
The time of event is unknown.There was no report of patient harm.Video image failure(Fluid damage).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893624 ↗MalfunctionSep 25, 2026Fluid/Blood Leak
The time of event is unknown.There was no report of patient harm.Video image failure (Cloudy).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893621 ↗MalfunctionSep 25, 2026Detachment of Device or Device Component
The time of event is unknown.There was no report of patient harm.Distal body peeled off (Black glue).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893620 ↗MalfunctionSep 25, 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 50893618 ↗MalfunctionSep 25, 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 50893615 ↗MalfunctionSep 25, 2026Fluid/Blood Leak
The time of event is unknown.There was no report of patient harm.Video image failure (Fluid damage).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893614 ↗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, 2026Detachment of Device or Device Component
The time of event is unknown.There was no report of patient harm.Bending rubber peeled off(Black glue).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877473 ↗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 ↗
Other Hoya Corporation products
All Hoya Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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