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EVIS EXERA II BRONCHOVIDEOSCOPERecalls & 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

10 open recalls name at least one EVIS EXERA II BRONCHOVIDEOSCOPE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports
671
Deaths reported
1
Injuries reported
68
Recalls
10

We found 12 models of EVIS EXERA II BRONCHOVIDEOSCOPE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 671 adverse event reports in the FDA's MAUDE database, received between Jul 13, 2018 and Sep 30, 2026 — classified as 1 death, 68 injuries, 602 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (269 reports).

10 FDA recall records name at least one of these models by its device identifier, 10 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: 26 reportsDec 2023: 15 reportsJan 2024: 16 reportsFeb 2024: 17 reportsMar 2024: 19 reportsApr 2024: 13 reportsMay 2024: 8 reportsJun 2024: 7 reportsJul 2024: 10 reportsAug 2024: 7 reportsSep 2024: 5 reportsOct 2024: 12 reportsNov 2024: 92 reportsDec 2024: 3 reportsJan 2025: 2 reportsFeb 2025: 4 reportsMar 2025: 6 reportsApr 2025: 5 reportsMay 2025: 6 reportsJun 2025: 6 reportsJul 2025: 8 reportsAug 2025: 9 reportsSep 2025: 2 reportsOct 2025: 4 reportsNov 2025: 4 reportsDec 2025: 17 reportsJan 2026: 17 reportsFeb 2026: 11 reportsMar 2026: 7 reportsApr 2026: 9 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 5 reportsAug 2026: 6 reportsSep 2026: 9 reportsOct 2026: 0 reports20242025202692
Last 36 months. The most recent month may be incomplete.

EVIS EXERA II BRONCHOVIDEOSCOPE 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 11, 2025Open, Classified

    Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

    Z-0062-2026 · Root cause: Device Design · Recall details · FDA record ↗

  2. Sep 11, 2025Open, Classified

    Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

    Z-0061-2026 · Root cause: Device Design · Recall details · FDA record ↗

  3. Sep 11, 2025Open, Classified

    Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

    Z-0056-2026 · Root cause: Device Design · Recall details · FDA record ↗

  4. Sep 11, 2025Open, Classified

    Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

    Z-0051-2026 · Root cause: Device Design · Recall details · FDA record ↗

  5. Sep 11, 2025Open, Classified

    Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

    Z-0046-2026 · Root cause: Device Design · Recall details · FDA record ↗

  6. Jul 27, 2023Open, Classified

    Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

    Z-2493-2023 · Root cause: Labeling Change Control · names 10 of these models · Recall details · FDA record ↗

  7. Jul 27, 2023Open, Classified

    Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

    Z-2492-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗

  8. Jun 8, 2023Open, Classified

    There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.

    Z-2016-2023 · Root cause: Under Investigation by firm · names 5 of these models · Recall details · FDA record ↗

  9. Jun 8, 2023Open, Classified

    There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.

    Z-2011-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  10. Mar 8, 2022Open, Classified

    Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization

    Z-1049-2022 · Root cause: Other · Recall details · FDA record ↗

Most reported EVIS EXERA II BRONCHOVIDEOSCOPE problems

Device problems

  • No Display/Image269
  • Thermal Decomposition of Device110
  • Peeled/Delaminated62
  • Microbial Contamination of Device53
  • Failure to Clean Adequately35
  • Device Reprocessing Problem26
  • Erratic or Intermittent Display22
  • Detachment of Device or Device Component21

Patient problems

  • No Clinical Signs, Symptoms or Conditions590
  • Bacterial Infection31
  • Unspecified Infection18
  • No Patient Involvement10
  • Respiratory Tract Infection6
  • Fungal Infection5
  • No Known Impact Or Consequence To Patient3
  • Pneumothorax3

EVIS EXERA II BRONCHOVIDEOSCOPE models

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

Recent EVIS EXERA II BRONCHOVIDEOSCOPE 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