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COLONOVIDEOSCOPERecalls & reported problems across all models

Olympus Medical Systems Corp. · 12 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names at least one COLONOVIDEOSCOPE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports
2,094
Deaths reported
0
Injuries reported
25
Recalls
1

We found 12 models of COLONOVIDEOSCOPE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 2,094 adverse event reports in the FDA's MAUDE database, received between Dec 22, 2019 and Sep 30, 2026 — classified as 25 injuries, 2,069 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (1,089 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 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

Nov 2023: 36 reportsDec 2023: 38 reportsJan 2024: 48 reportsFeb 2024: 53 reportsMar 2024: 44 reportsApr 2024: 55 reportsMay 2024: 42 reportsJun 2024: 45 reportsJul 2024: 39 reportsAug 2024: 50 reportsSep 2024: 49 reportsOct 2024: 74 reportsNov 2024: 27 reportsDec 2024: 9 reportsJan 2025: 12 reportsFeb 2025: 8 reportsMar 2025: 18 reportsApr 2025: 14 reportsMay 2025: 18 reportsJun 2025: 8 reportsJul 2025: 21 reportsAug 2025: 7 reportsSep 2025: 12 reportsOct 2025: 24 reportsNov 2025: 51 reportsDec 2025: 151 reportsJan 2026: 150 reportsFeb 2026: 52 reportsMar 2026: 85 reportsApr 2026: 92 reportsMay 2026: 93 reportsJun 2026: 84 reportsJul 2026: 77 reportsAug 2026: 93 reportsSep 2026: 74 reportsOct 2026: 0 reports202420252026151
Last 36 months. The most recent month may be incomplete.

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. Sep 25, 2023Open, 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 ↗

Most reported COLONOVIDEOSCOPE problems

Device problems

  • Failure to Clean Adequately1,089
  • Communication or Transmission Problem241
  • No Display/Image146
  • Device Reprocessing Problem128
  • Poor Quality Image111
  • Residue After Decontamination108
  • Microbial Contamination of Device84
  • Contamination76

Patient problems

  • No Clinical Signs, Symptoms or Conditions2,058
  • No Consequences Or Impact To Patient8
  • Abdominal Pain5
  • Ascites5
  • Bacteremia5
  • Granuloma5
  • Intra-Abdominal Hemorrhage5
  • Nausea5

COLONOVIDEOSCOPE models

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

Recent COLONOVIDEOSCOPE adverse event reports

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

Other Olympus Medical Systems Corp. products

All Olympus Medical Systems Corp. devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page