PENTAX OF-B194Recalls & reported problems
Hoya Corporation · PENTAX GAS/WATER FEEDING VALVE · Class 2
All models of PENTAX (72)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04961333148028), received between Jul 30, 2021 and Jul 30, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Open or Close” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K850020); 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.
Most reported problems
Device problems
- Difficult to Open or Close1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2021Difficult to Open or Close; Difficult to Open or Close
THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. DURING SOME EXAMINATIONS THE VALVE STUCK. THIS HAPPENED DURING LONG EXAMINATIONS OR IF THE PATIENT IS NOT CLEANED WELL. THE USER KNOW THIS AND KNOW HOW TO COUNTERACT IT. THERE IS NO PATIENT OR USER HURT!!!
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12250895 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K850020. One submission often covers many models, so check the product and lot details in each record.
- Z-2071-2016 · Apr 6, 2016 · TerminatedGastroscope Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, ti
- Z-2290-2014 · Jul 17, 2014 · TerminatedPENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
- Z-0084-2014 · Sep 16, 2013 · TerminatedPENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Wate
Other Gastroscope and accessories, flexible/rigid devices
- PENTAX Medical EG29-i10cHoya Corporation · Gastroscope And Accessories, Flexible/Rigid1,623 reports
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1TH190Olympus Medical Systems Corp. · Gastroscope And Accessories, Flexible/Rigid4 recalls6 deaths1,025 reports
- EVIS EXERA lll GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-XP190NOlympus Medical Systems Corp. · Gastroscope and accessories, flexible/rigid1 recall559 reports
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GIF-Q165Olympus Medical Systems Corp. · Gastroscope and accessories, flexible/rigid349 reports
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE H180Olympus Medical Systems Corp. · Gastroscope and accessories, flexible/rigid1 death302 reports
- PENTAX EG27-i10Hoya Corporation · Gastroscope and accessories, flexible/rigid261 reports
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180ALOlympus Medical Systems Corp. · Gastroscope and accessories, flexible/rigid2 deaths252 reports
- BALLOON MAJ-1351Olympus Medical Systems Corp. · Gastroscope and accessories, flexible/rigid174 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
- 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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