PENTAXRecalls & reported problems across all models
Hoya Corporation · 72 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4,738
- Deaths reported
- 0
- Injuries reported
- 88
- Recalls
- 0
We found 72 models of PENTAX by Hoya Corporation in the FDA's device registry (GUDID). Together they are named in 4,738 adverse event reports in the FDA's MAUDE database, received between Feb 26, 2020 and Sep 30, 2026 — classified as 88 injuries, 4,650 malfunctions.
The most frequently reported specific device problem is “Break” (1,303 reports).
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
Most reported PENTAX problems
Device problems
- Break1,303
- Fluid/Blood Leak770
- Detachment of Device or Device Component656
- No Display/Image389
- Optical Obstruction343
- Obstruction of Flow339
- Erratic or Intermittent Display310
- Optical Distortion155
Patient problems
- No Clinical Signs, Symptoms or Conditions4,663
- Insufficient Information77
- No Known Impact Or Consequence To Patient26
- Internal Organ Perforation8
- Laceration(s)8
- No Patient Involvement6
- Device Embedded In Tissue or Plaque5
- Hematoma4
PENTAX models
72 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PENTAX EC34-i10LColonoscope and accessories, flexible/rigid848 reports
- PENTAX EC-3490LiColonoscope and accessories, flexible/rigid481 reports
- PENTAX FNL-10RP3NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)322 reports
- PENTAX EG27-i10Gastroscope and accessories, flexible/rigid261 reports
- PENTAX FNL-7RP3NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)227 reports
- PENTAX EC38-i10LColonoscope and accessories, flexible/rigid212 reports
- PENTAX EC38-i10LColonoscope and accessories, flexible/rigid191 reports
- PENTAX FNL-10RBSNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)171 reports
- PENTAX EG-3870UTKEndoscopic ultrasound system, gastroenterology-urology164 reports
- PENTAX EC-3890LiColonoscope and accessories, flexible/rigid163 reports
- PENTAX EG-2990iGastroscope and accessories, flexible/rigid156 reports
- PENTAX EG29-i10Gastroscope and accessories, flexible/rigid130 reports
- PENTAX EG29-i10Gastroscope and accessories, flexible/rigid125 reports
- PENTAX EG-2790iGastroscope and accessories, flexible/rigid113 reports
- PENTAX EB-1970UKBRONCHOSCOPE (FLEXIBLE OR RIGID)90 reports
- PENTAX EC-3490TLiColonoscope and accessories, flexible/rigid73 reports
- PENTAX EG-3670URKEndoscopic ultrasound system, gastroenterology-urology72 reports
- PENTAX FB-15VBRONCHOSCOPE (FLEXIBLE OR RIGID)66 reports
- PENTAX EC-3890LKColonoscope and accessories, flexible/rigid62 reports
- PENTAX EG-1690KGastroscope and accessories, flexible/rigid54 reports
- PENTAX FB-15RBSBRONCHOSCOPE (FLEXIBLE OR RIGID)49 reports
- PENTAX FNL-15RP3NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)48 reports
- PENTAX OE-A52BRONCHOSCOPE (FLEXIBLE OR RIGID)47 reports
- PENTAX EG-2990KGastroscope and accessories, flexible/rigid44 reports
- PENTAX EB-1575KBRONCHOSCOPE (FLEXIBLE OR RIGID)43 reports
- PENTAX ED-3490TKduodenoscope and accessories, flexible/rigid43 reports
- PENTAX EC-3490LKColonoscope and accessories, flexible/rigid42 reports
- PENTAX FCY-15RBSCystoscope and accessories, flexible/rigid39 reports
- PENTAX EC-3890TLKColonoscope and accessories, flexible/rigid33 reports
- PENTAX EC-2990LiColonoscope and accessories, flexible/rigid31 reports
- PENTAX EG-2790KGastroscope and accessories, flexible/rigid29 reports
- PENTAX EG-2490KGastroscope and accessories, flexible/rigid25 reports
- PENTAX FB-10VBRONCHOSCOPE (FLEXIBLE OR RIGID)23 reports
- PENTAX FB-8VBRONCHOSCOPE (FLEXIBLE OR RIGID)23 reports
- PENTAX FB-18VBRONCHOSCOPE (FLEXIBLE OR RIGID)22 reports
- PENTAX FG-29VGastroscope and accessories, flexible/rigid20 reports
- PENTAX EG-3890TKGastroscope and accessories, flexible/rigid19 reports
- PENTAX FB-18RBSBRONCHOSCOPE (FLEXIBLE OR RIGID)17 reports
- PENTAX EG-2990iGastroscope and accessories, flexible/rigid16 reports
- PENTAX EC-3890LZiColonoscope and accessories, flexible/rigid14 reports
- PENTAX VNL-1570STKNasopharyngoscope (Flexible Or Rigid)12 reports
- PENTAX FB-19TVBRONCHOSCOPE (FLEXIBLE OR RIGID)11 reports
- PENTAX EG-3490KGastroscope and accessories, flexible/rigid10 reports
- PENTAX EG-3270UKEndoscopic Ultrasound System, Gastroenterology-Urology10 reports
- PENTAX EB-1975KBRONCHOSCOPE (FLEXIBLE OR RIGID)9 reports
- PENTAX KW1818CSEndoscopic ultrasound system, gastroenterology-urology8 reports
- PENTAX EC38-i10LColonoscope and accessories, flexible/rigid8 reports
- PENTAX EE-1580KGastroscope and accessories, flexible/rigid7 reports
- PENTAX ES-3870Ksigmoidoscope and accessories, flexible/rigid6 reports
- PENTAX OF-B120Colonoscope and accessories, flexible/rigid5 reports
- PENTAX FG-24VGastroscope and accessories, flexible/rigid5 reports
- PENTAX OF-B113Colonoscope and accessories, flexible/rigid4 reports
- PENTAX OF-A67Endoscopic ultrasound system, gastroenterology-urology3 reports
- PENTAX ED-3490TKduodenoscope and accessories, flexible/rigid3 reports
- PENTAX EB-1570KBRONCHOSCOPE (FLEXIBLE OR RIGID)3 reports
- PENTAX EC-3890LiColonoscope and accessories, flexible/rigid3 reports
- PENTAX EG29-i10Gastroscope and accessories, flexible/rigid3 reports
- PENTAX OE-A51Endoscopic ultrasound system, gastroenterology-urology2 reports
- PENTAX EB-1990iBRONCHOSCOPE (FLEXIBLE OR RIGID)2 reports
- PENTAX OF-B218Nasopharyngoscope (Flexible Or Rigid)2 reports
- PENTAX FUR-9RBSUreteroscope and accessories, flexible/rigid2 reports
- PENTAX EC34-i10LColonoscope and accessories, flexible/rigid2 reports
- PENTAX CS6021SNEndoscopic ultrasound system, gastroenterology-urology1 report
- PENTAX OF-B121duodenoscope and accessories, flexible/rigid1 report
- PENTAX OF-B194Gastroscope and accessories, flexible/rigid1 report
- PENTAX EG-290KpGastroscope and accessories, flexible/rigid1 report
- PENTAX EPK-i5010Endoscope, accessories, image post-processing for color enhancement1 report
- PENTAX EB-1970TKBRONCHOSCOPE (FLEXIBLE OR RIGID)1 report
- PENTAX BS-LL1BRONCHOSCOPE (FLEXIBLE OR RIGID)1 report
- PENTAX VSB-3430KGastroscope and accessories, flexible/rigid1 report
- PENTAX EB-1970KBRONCHOSCOPE (FLEXIBLE OR RIGID)1 report
- PENTAX EC-2990LiColonoscope and accessories, flexible/rigid1 report
Recent PENTAX adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 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 50942352 ↗MalfunctionSep 25, 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 50893628 ↗MalfunctionSep 18, 2026Optical Obstruction
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 50813599 ↗MalfunctionSep 11, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50726260 ↗MalfunctionSep 11, 2026Optical Obstruction
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 50726258 ↗MalfunctionSep 3, 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 50579749 ↗MalfunctionSep 2, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50558340 ↗MalfunctionSep 2, 2026Optical Obstruction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50558333 ↗MalfunctionSep 1, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50536433 ↗MalfunctionSep 1, 2026Detachment of Device or Device Component
The time of event is unknown.There was no report of patient harm.Air/Water Nozzle peeled off (Black glue).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50536429 ↗MalfunctionAug 31, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50515235 ↗MalfunctionAug 28, 2026Optical Obstruction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50490890 ↗MalfunctionAug 18, 2026Optical Obstruction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50292713 ↗MalfunctionAug 18, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50292697 ↗MalfunctionAug 17, 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 50269343 ↗
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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