PENTAX FG-24VRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04961333223985), received between Apr 4, 2022 and May 12, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2023Break; Break

  THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16917039 ↗
• MalfunctionJun 10, 2022Break; Break

  THE TIME OF EVENT IS UNKNOWN.THERE WAS NO REPORT OF PATIENT HARM.VIDEO IMAGE FAILURE(OBJECTIVE LENS BROKEN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14652033 ↗
• MalfunctionApr 27, 2022Break; Break

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(OBJECTIVE LENS BROKEN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14216026 ↗
• MalfunctionApr 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE (FLUID DAMAGE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14133246 ↗
• MalfunctionApr 4, 2022Break; Break

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13992834 ↗

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 · Terminated
  Gastroscope 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 · Terminated
  PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
• Z-0084-2014 · Sep 16, 2013 · Terminated
  PENTAX 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