PENTAX EG-2490KRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 04961333225651), received between Jun 26, 2020 and May 14, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 reports).

2 other recalls cover devices cleared under the same FDA submission (K131902); 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Obstruction of Flow

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. OPERATION/SUCTION CHANNEL CLOGGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25167937 ↗
• MalfunctionMar 26, 2025Optical Obstruction; Optical 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 21694833 ↗
• MalfunctionMar 3, 2025Detachment of Device or Device Component; Detachment 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 21501500 ↗
• MalfunctionDec 3, 2024No Display/Image; No 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 20828669 ↗
• MalfunctionOct 28, 2024Fluid/Blood Leak; Fluid/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 20542159 ↗
• MalfunctionOct 10, 2024Fluid/Blood Leak; Fluid/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 20414400 ↗
• MalfunctionJul 26, 2024No Display/Image; No 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 19834747 ↗
• MalfunctionJul 1, 2024No Display/Image; No 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 19641400 ↗
• MalfunctionJun 26, 2024Erratic or Intermittent Display; Erratic 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 19612254 ↗
• MalfunctionApr 12, 2024No Display/Image; No 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 19094365 ↗
• MalfunctionMar 11, 2024No Display/Image; No 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 18872774 ↗
• MalfunctionNov 15, 2023No Display/Image; No 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 18137378 ↗
• MalfunctionNov 1, 2023Obstruction of Flow; Obstruction of Flow

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. OPERATION/SUCTION CHANNEL CLOGGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18045316 ↗
• MalfunctionOct 16, 2023Detachment of Device or Device Component; Detachment 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 17937530 ↗
• MalfunctionFeb 21, 2023Detachment of Device or Device Component; Detachment 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 16406719 ↗
• MalfunctionNov 10, 2022Component Missing; Component Missing

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER NOZZLE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15768123 ↗
• MalfunctionSep 19, 2022Detachment of Device or Device Component; Detachment 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 15452465 ↗
• MalfunctionSep 16, 2022Fluid/Blood Leak; Fluid/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 15436041 ↗
• MalfunctionJul 1, 2022Detachment of Device or Device Component; Detachment 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 14882519 ↗
• MalfunctionJun 30, 2022Detachment of Device or Device Component; Detachment 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 14869124 ↗
• MalfunctionJun 17, 2022Component Missing; Component Missing

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER NOZZLE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14728433 ↗
• MalfunctionJun 8, 2022Detachment of Device or Device Component; Detachment 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 14629493 ↗
• MalfunctionJun 7, 2022Detachment of Device or Device Component; Detachment 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 14612609 ↗
• MalfunctionFeb 24, 2022Fluid/Blood Leak; Fluid/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 13589628 ↗
• MalfunctionJun 26, 2020Break; Device Reprocessing Problem; Break; Device Reprocessing Problem

  PENTAX MEDICAL WAS MADE AWARE OF AN EVENT ON (B)(6) 2020 THAT OCCURRED AT THE (B)(6) INVOLVING PENTAX MEDICAL VIDEO GASTROSCOPE, MODEL EG-2490K, SERIAL NUMBER (B)(4). THE USER FACILITY CALLED IN AN ENDOSCOPE FOR EVALUATION REPORTING "POSSIBLE METAL SHAVINGS IN THE CHANNEL." BASED ON GOOD FAITH EFFORT RESPONSES RECEIVED FROM THE USER FACILITY ON 14-MAY-2020 AND 18-MAY-2020 VIA EMAIL, PENTAX LEARNED THAT THERE WERE NO ACCESSORIES USED DURING AN INTESTINAL BIOPSY PROCEDURE. THE USER FLUSHED THE PRIMATE WITH WATER AND SUCTIONED BACK AND FORTH A FEW TIMES TO TRY TO REMOVE ANY AND AS MUCH OF THE REPORTED DEBRIS AS POSSIBLE. THERE WERE NO REPORTED SERIOUS INJURY OR DEATH OF A PATIENT OR USER, OR DELAY IN THE PROCEDURE WHICH WOULD REQUIRE MEDICAL INTERVENTION; AND THE ENDOSCOPE WAS USED TO COMPLETE THE PROCEDURE. THE ENDOSCOPE WAS THEN REMOVED FROM CIRCULATION AND SUBSEQUENTLY CALLED IN FOR SERVICE. THE USER FACILITY ALSO ALERTED US THAT THE ENDOSCOPE WAS USED ON NON HUMAN PRIMATES. THE DATE OF OCCURRENCE IS UNKNOWN BUT THE USER DID STATE THAT THE PROCEDURE WAS A FEW WEEKS PRIOR AND THE ANIMAL IS FINE. THE GASTROSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 11-JUN-2020. THE GASTRO

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10203188 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131902. One submission often covers many models, so check the product and lot details in each record.

• Z-0318-2017 · Aug 15, 2016 · Terminated
  Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy Device such as a Biopsy Forcep
• 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