EVIS EXERA lll COLONOVIDEOSCOPERecalls & reported problems across all models

We found 16 models of EVIS EXERA lll COLONOVIDEOSCOPE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 15,013 adverse event reports in the FDA's MAUDE database, received between Oct 6, 2017 and Sep 30, 2026 — classified as 5 deaths, 174 injuries, 14,834 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (6,389 reports).

7 FDA recall records name at least one of these models by its device identifier, 7 still open.

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

EVIS EXERA lll COLONOVIDEOSCOPE recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 11, 2024Class IIOpen, Classified

   Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

   Z-1211-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Jan 11, 2024Class IIOpen, Classified

   Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

   Z-1207-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

3. Jan 11, 2024Class IIOpen, Classified

   Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

   Z-1206-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

4. Oct 16, 2023Class IIOpen, Classified

   Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.

   Z-0419-2024 · Root cause: Process control · Recall details · FDA record ↗

5. Oct 16, 2023Class IIOpen, Classified

   Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.

   Z-0415-2024 · Root cause: Process control · Recall details · FDA record ↗

6. Sep 25, 2023Class IIOpen, Classified

   Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

   Z-0341-2024 · Root cause: Under Investigation by firm · names 4 of these models · Recall details · FDA record ↗

7. Sep 25, 2023Class IIOpen, Classified

   Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

   Z-0329-2024 · Root cause: Under Investigation by firm · names 4 of these models · Recall details · FDA record ↗

Most reported EVIS EXERA lll COLONOVIDEOSCOPE problems

EVIS EXERA lll COLONOVIDEOSCOPE models

16 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-HQ190L

  Colonoscope and accessories, flexible/rigid
  3 recalls2 deaths6,804 reports
• EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS PCF-H190L

  Colonoscope and accessories, flexible/rigid
  3 recalls2 deaths2,513 reports
• EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-H190I

  Colonoscope and accessories, flexible/rigid
  1 recall1,967 reports
• EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-HQ190I

  Colonoscope and accessories, flexible/rigid
  2 recalls1,315 reports
• EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-H190L

  Colonoscope and accessories, flexible/rigid
  1 recall1 death1,194 reports
• EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS PCF-H190I

  Colonoscope and accessories, flexible/rigid
  1 recall460 reports
• EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-HQ190L

  Colonoscope And Accessories, Flexible/Rigid
  250 reports
• EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS PCF-PH190L

  Colonoscope and accessories, flexible/rigid
  1 recall139 reports
• EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-H190L

  Colonoscope And Accessories, Flexible/Rigid
  99 reports
• EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS PCF-PH190I

  Colonoscope and accessories, flexible/rigid
  1 recall47 reports
• EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS PCF-H190L

  Colonoscope And Accessories, Flexible/Rigid
  86 reports
• EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-H190I

  Colonoscope And Accessories, Flexible/Rigid
  66 reports
• EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-HQ190I

  Colonoscope And Accessories, Flexible/Rigid
  45 reports
• EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS PCF-H190I

  Colonoscope And Accessories, Flexible/Rigid
  14 reports
• EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS PCF-PH190L

  Colonoscope And Accessories, Flexible/Rigid
  10 reports
• EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS PCF-PH190I

  Colonoscope And Accessories, Flexible/Rigid
  4 reports

Recent EVIS EXERA lll COLONOVIDEOSCOPE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Poor Quality Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954447 ↗
• MalfunctionSep 30, 2026Erratic or Intermittent Display; Poor Quality Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953468 ↗
• MalfunctionSep 30, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953192 ↗
• MalfunctionSep 30, 2026Residue After Decontamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953005 ↗
• MalfunctionSep 30, 2026Failure to Clean Adequately

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952662 ↗
• MalfunctionSep 30, 2026Failure to Clean Adequately

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952653 ↗
• MalfunctionSep 30, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951586 ↗
• MalfunctionSep 30, 2026Poor Quality Image

  The customer reported a fuzzy image with white specks during the pre-use inspection of an Olympus Colonovideoscope. During the initial device evaluation, a noisy image condition was confirmed. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950819 ↗
• MalfunctionSep 30, 2026Residue After Decontamination

  The customer reported the colonovideoscope had a black piece that had removed from inside the tube. During the initial evaluation of the device, foreign material in the biopsy channel was observed. There was no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950806 ↗
• MalfunctionSep 30, 2026No Display/Image; Communication or Transmission Problem

  The customer reported the videoscope experienced error code B30 during set up / inspection for use. During the initial evaluation of the device it was observed that there was no image. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950026 ↗
• MalfunctionSep 30, 2026Poor Quality Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950006 ↗
• MalfunctionSep 30, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949914 ↗
• MalfunctionSep 30, 2026No Display/Image

  The customer reported that no image was displayed during inspection for use involving an olympus colonovideoscope. There were no reports of patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949574 ↗
• MalfunctionSep 30, 2026Failure to Clean Adequately

  The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, white residue at air water channel, cylinder and auxiliary water channel was observed. No patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948946 ↗
• MalfunctionSep 30, 2026Erratic or Intermittent Display

  It was reported that during a therapeutic colonoscopy, the colonovideoscope's monitor image blacked out for 1-5 seconds. The procedure was completed using the same device.During the initial device evaluation, the scope's image was flickering. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948758 ↗

Other Olympus Medical Systems Corp. products

• EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
• EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
• EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
• EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
• EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
• EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
• HD CAMERA HEAD2 models · 5,217 reports
• 4K CAMERA HEAD3 models · 4,926 reports