EVIS EXERA II COLONOVIDEOSCOPERecalls & reported problems across all models
Olympus Medical Systems Corp. · 28 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
7 open recalls name at least one EVIS EXERA II COLONOVIDEOSCOPE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2,142
- Deaths reported
- 3
- Injuries reported
- 70
- Recalls
- 8
We found 28 models of EVIS EXERA II COLONOVIDEOSCOPE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 2,142 adverse event reports in the FDA's MAUDE database, received between Oct 10, 2017 and Sep 30, 2026 — classified as 3 deaths, 70 injuries, 2,069 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (826 reports).
8 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
Reports received per month, all models
EVIS EXERA II 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.
- 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-1214-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- 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-1209-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- 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-1208-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- 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-1205-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- 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 ↗
- 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 6 of these models · Recall details · FDA record ↗
- Dec 21, 2022Class IIOpen, Classified
A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in error, potential for microbial contamination
Z-1132-2023 · Root cause: Process design · Recall details · FDA record ↗
- Apr 22, 2022Class IITerminated
A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the CF-H180AL, viewing angle would be narrower than a normal CF-H180AL and the use of EndoTherapy devices may stick out (approximately 1.4 mm) further than normal protrusion,could lead to patient injury; specifically, mucosal damage that could result in hemorrhage or bleeding
Z-1274-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported EVIS EXERA II COLONOVIDEOSCOPE problems
Device problems
- Failure to Clean Adequately826
- Device Reprocessing Problem282
- Microbial Contamination of Device262
- No Display/Image199
- Poor Quality Image172
- Erratic or Intermittent Display86
- Contamination47
- Corroded44
Patient problems
- No Clinical Signs, Symptoms or Conditions1,910
- No Known Impact Or Consequence To Patient103
- No Consequences Or Impact To Patient41
- Bowel Perforation23
- Hemorrhage/Blood Loss/Bleeding20
- No Patient Involvement15
- Perforation12
- Insufficient Information5
EVIS EXERA II COLONOVIDEOSCOPE models
28 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180ALColonoscope and accessories, flexible/rigid1 recall323 reports
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180ALGastroscope and accessories, flexible/rigid2 deaths252 reports
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE H180ALColonoscope and accessories, flexible/rigid251 reports
- EVIS EXERA II COLONOVIDEOSCOPE CF-Q165LColonoscope and accessories, flexible/rigid184 reports
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180ALGastroscope and accessories, flexible/rigid2 recalls72 reports
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180AIColonoscope and accessories, flexible/rigid1 recall117 reports
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180AIColonoscope and accessories, flexible/rigid145 reports
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180ALEndoscope, accessories, narrow band spectrum1 recall83 reports
- EVIS EXERA II COLONOVIDEOSCOPE CF-Q165IColonoscope and accessories, flexible/rigid127 reports
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE H180ALEndoscope, accessories, narrow band spectrum2 recalls25 reports
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE Q180ALColonoscope and accessories, flexible/rigid119 reports
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE Q180ALGastroscope and accessories, flexible/rigid2 recalls6 reports
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180ALColonoscope and accessories, flexible/rigid2 recalls5 reports
- EVIS EXERA II COLONOVIDEOSCOPE CF-Q165LColonoscope and accessories, flexible/rigid92 reports
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE H180AIGastroscope and accessories, flexible/rigid1 recall17 reports
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AIEndoscope, accessories, narrow band spectrum1 recall16 reports
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE H180ALEndoscope, accessories, narrow band spectrum1 death60 reports
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180DLGastroscope and accessories, flexible/rigid1 recall9 reports
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180DIGastroscope and accessories, flexible/rigid1 recall4 reports
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE Q180AIEndoscope, accessories, narrow band spectrum1 recall1 report
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE Q180ALEndoscope, accessories, narrow band spectrum47 reports
- EVIS EXERA II COLONOVIDEOSCOPE CF-Q165IColonoscope and accessories, flexible/rigid46 reports
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE H180AIColonoscope and accessories, flexible/rigid42 reports
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180ALGastroscope and accessories, flexible/rigid37 reports
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE H180ALEndoscope, accessories, narrow band spectrum34 reports
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE Q180AIEndoscope, accessories, narrow band spectrum11 reports
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180AIColonoscope and accessories, flexible/rigid10 reports
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE H180AIGastroscope and accessories, flexible/rigid7 reports
Recent EVIS EXERA II 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, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952875 ↗MalfunctionSep 30, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951833 ↗MalfunctionSep 30, 2026Device Reprocessing Problem
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, foreign material on scope cover and light guide lens were observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951367 ↗MalfunctionSep 30, 2026Failure to Clean Adequately
The customer reported that dark black liquid was leaking from the working channel of an olympus colonovideoscope. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948381 ↗MalfunctionSep 30, 2026Corroded
The customer reported the colonovideoscope had a separate issue. During the initial evaluation of the device it was observed, light guide lens has corrosion. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943528 ↗MalfunctionSep 25, 2026Failure to Clean Adequately
The customer reported the colonovideoscope had a separate issue. During the initial evaluation of the device, it was observed that water supply and white air water channel has white residue. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899844 ↗MalfunctionSep 25, 2026Contamination
The customer returned the Colonovideoscope for a separate issue. During the initial evaluation of the returned device, foreign objects were observed on the light guide lens. Additionally, the shield plate and disk were found to be dirty. There was no patient involvement.
Patient problems: Insufficient Information
MAUDE report 50898308 ↗MalfunctionSep 25, 2026Poor Quality Image
The customer reported the colonovideoscope had static monitor connection during inspection for use. During the initial evaluation of the device, static and noise in the image were observed. No patient involvement was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892965 ↗MalfunctionSep 24, 2026Corroded; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892354 ↗MalfunctionSep 24, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889734 ↗MalfunctionSep 24, 2026Failure to Clean Adequately
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, white residue in air water channel and cylinder. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50888874 ↗MalfunctionSep 24, 2026No Display/Image
The customer reported that no image was visible during inspection prior to use involving an Olympus colonovideoscope. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880729 ↗MalfunctionSep 24, 2026Failure to Clean Adequately
The customer returned the colonovideoscope to the service center for a separate issue. During the device analysis, the technical assistance indicates that a black foreign material at nozzle was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876998 ↗MalfunctionSep 23, 2026Erratic or Intermittent Display; No Display/Image; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875856 ↗MalfunctionSep 23, 2026Device Reprocessing Problem
The customer reported the colonovideoscope for a separate issue. During the initial evaluation of the device, the foreign objects at control section and scope connector was observed. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870611 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- 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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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