PENTAX VNL-1570STKRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04961333233809), received between Oct 16, 2020 and Aug 12, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (6 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, 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

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50217982 ↗
• MalfunctionMay 7, 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 25108329 ↗
• MalfunctionApr 24, 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 24975485 ↗
• MalfunctionOct 15, 2025No 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 23287371 ↗
• MalfunctionSep 19, 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 20254349 ↗
• MalfunctionAug 17, 2022Break; Break

  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 15238671 ↗
• MalfunctionJul 31, 2021No Display/Image; No Display/Image

  D050203 DISPLAY IS UNSTABLE, D05021101 NO DISPLAY (BLANK SCREEN). THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12257142 ↗
• MalfunctionJul 30, 2021No Display/Image; No Display/Image

  D050203 DISPLAY IS UNSTABLE,D05021101 NO DISPLAY (BLANK SCREEN). THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250923 ↗
• MalfunctionJul 28, 2021No Display/Image; No Display/Image

  DURING USE, NO IMAGE APPEARED SUDDENLY. CHECKING THE DEVICE, THERE WAS NO LIGHT SOURCE AND CHANGED ANOTHER ONE TO CONTINUE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12236980 ↗
• MalfunctionJul 24, 2021Moisture Damage; Optical Distortion; Moisture Damage; Optical Distortion

  THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. DURING USE, THE IMAGE BECAME FOGGY SUDDENLY. THE USER STOPPED USING THIS SCOPE AND CHANGED ANOTHER ONE TO COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222450 ↗
• MalfunctionOct 16, 2020Device Reprocessing Problem; Device Reprocessing Problem

  PENTAX MEDICAL WAS MADE AWARE OF AN EVENT THAT OCCURRED AFTER REPROCESSING IN THE UNITED STATES. THE REPORTED COMPLAINT THAT THERE IS POTENTIAL ENDOSCOPE CONTAMINATION. AFTER REPROCESSING, WHITE RESIDUE WAS OBSERVED WITHIN THE CHANNEL WHILE EXAMINING THE PENTAX ENDOSCOPE WITH A BORESCOPE, INVOLVING THE PENTAX MEDICAL VIDEO NASO-PHARYNGO-LARYNGOSCOPE(VNL) , MODEL VNL-1570STK., SERIAL NUMBER (B)(4). NO PATIENT INVOLVEMENT WAS REPORTED. THE ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 23-SEP-2020. THE ENDOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE UNDER SERVICE ORDER (B)(4) AND THE TECHNICIAN DOCUMENTED THE FOLLOWING INSPECTION FINDINGS ON 28-SEP-2020: OPERATION CHANNEL- PRIMARY MILD RESISTANCE, PASSED DRY LEAK TEST, PASSED WET LEAK TEST, HOLE IN # 4 REMOTE CONTROL BUTTON COVER, FLUID INVASION NOT OBSERVED IN PVE CONNECTOR, FLUID INVASION NOT OBSERVED IN CONTROL BODY. THE ENDOSCOPE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: R.C. BUTTON (4) PB-FREE, O-RINGS AND SEALS. PENTAX MEDICAL, MODEL VNL-1570STK., SERIAL NUMBER (B)(4) HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON (B)(6) 2014. THE ENDOSCOPE WAS DELIVERED TO TH

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

  MAUDE report 10693216 ↗
• MalfunctionOct 16, 2020Device Reprocessing Problem; Device Reprocessing Problem

  PENTAX MEDICAL WAS MADE AWARE OF AN EVENT THAT OCCURRED AFTER REPROCESSING IN THE UNITED STATES. THE REPORTED COMPLAINT THAT THERE IS POTENTIAL ENDOSCOPE CONTAMINATION. AFTER REPROCESSING, WHITE RESIDUE WAS OBSERVED WITHIN THE CHANNEL WHILE EXAMINING THE PENTAX ENDOSCOPE WITH A BORESCOPE, INVOLVING THE PENTAX MEDICAL VIDEO NASO-PHARYNGO-LARYNGOSCOPE(VNL) , MODEL VNL-1570STK., SERIAL NUMBER (B)(4). NO PATIENT INVOLVEMENT WAS REPORTED. THE ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 23-SEP-2020. THE ENDOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE UNDER SERVICE ORDER (B)(4), AND THE TECHNICIAN DOCUMENTED THE FOLLOWING INSPECTION FINDINGS ON 28-SEP-2020: INSERTION TUBE BUCKLES UNDER THE ROOT BRACE, PASSED WET LEAK TEST, LONG UMBILICAL CABLE BUMP, SHORT UMBILICAL CABLE BUMP, INSERTION TUBE ABRASION, PASSED DRY LEAK TEST, #4 REMOTE CONTROL BUTTON INTERMITTENT FUNCTION, CUT ON INSERTION TUBE AT STAGE 1, FLUID INVASION NOT OBSERVED IN PVE CONNECTOR, FLUID INVASION NOT OBSERVED IN CONTROL BODY, OPERATION CHANNEL- PRIMARY MILD SCRATCH INSIDE, HOLE IN # 4 REMOTE CONTROL BUTTON COVER. THE ENDOSCOPE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: O-RINGS AND SEALS, R.C. B

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

  MAUDE report 10692176 ↗