ENDOSCOPE REPROCESSORRecalls & reported problems across all models

We found 3 models of ENDOSCOPE REPROCESSOR by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 1,497 adverse event reports in the FDA's MAUDE database, received between Oct 3, 2019 and Sep 30, 2026 — classified as 39 injuries, 1,458 malfunctions.

The most frequently reported specific device problem is “Break” (383 reports).

9 FDA recall records name at least one of these models by its device identifier, 8 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

ENDOSCOPE REPROCESSOR 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. Feb 12, 2026Open, Classified

   The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

   Z-1613-2026 · Root cause: Reprocessing Controls · Recall details · FDA record ↗

2. Feb 12, 2026Open, Classified

   The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

   Z-1612-2026 · Root cause: Reprocessing Controls · Recall details · FDA record ↗

3. Oct 31, 2025Open, Classified

   Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

   Z-0874-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Oct 31, 2025Open, Classified

   Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

   Z-0873-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. Oct 31, 2025Open, Classified

   Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

   Z-0872-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. May 26, 2023Open, Classified

   Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible

   Z-2344-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗

7. May 26, 2023Open, Classified

   Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible

   Z-2343-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗

8. May 26, 2023Open, Classified

   Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible

   Z-2342-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗

9. Dec 13, 2021Terminated

   The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed instead of detergent for the cleaning cycle and detergent will be dispensed instead of alcohol for the alcohol cycle, resulting in a ineffective endoscope reprocessing and patient exposure to residual detergent

   Z-0638-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported ENDOSCOPE REPROCESSOR problems

ENDOSCOPE REPROCESSOR models

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

• ENDOSCOPE REPROCESSOR OER-Pro

  ACCESSORIES, CLEANING, FOR ENDOSCOPE
  3 recalls1,163 reports
• ENDOSCOPE REPROCESSOR OER-Elite

  Accessories, cleaning, for endoscope
  4 recalls323 reports
• ENDOSCOPE REPROCESSOR OER-MINI

  Accessories, Cleaning, For Endoscope
  2 recalls11 reports

Recent ENDOSCOPE REPROCESSOR adverse event reports

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

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  The customer reported a patient allegation of sepsis following a colonoscopy procedure performed in 2024. The customer inquired whether either of the Olympus endoscope reprocessors had been subject to a recall. No further information was provided. This report is 2 of 2.

  Patient problems: Sepsis

  MAUDE report 50950162 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  The customer reported a patient allegation of sepsis following a colonoscopy procedure performed in 2024. The customer inquired whether either of the Olympus endoscope reprocessors had been subject to a recall. No further information was provided. This report is 2 of 2.

  Patient problems: Sepsis

  MAUDE report 50950065 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  The customer reported a patient allegation of sepsis following a colonoscopy procedure performed in 2024. The customer inquired whether either of the Olympus endoscope reprocessors had been subject to a recall. No further information was provided. This report is 1 of 2.

  Patient problems: Sepsis

  MAUDE report 50950028 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Sepsis

  MAUDE report 50949747 ↗
• MalfunctionSep 29, 2026Filling Problem

  A Field Service Engineer (FSE) was dispatched to the user facility for a separate issue. During the inspection of the Endoscope Reprocessor, no water was supplied to the disinfectant tank. After changing the water filter and servicing the reprocessor and adjusting the external water flow regulator at the facility the water flows properly into the basin. The device was working as intended. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936316 ↗
• MalfunctionSep 28, 2026Residue After Decontamination

  The customer reported blacks specs present in reprocessing basin after a cycle is completed. This event occurred during reprocessing involving an Olympus Endoscope Reprocessor. There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913735 ↗
• MalfunctionSep 18, 2026Filling Problem

  The customer reported the reprocessing time was longer on the Endoscope Reprocessor due to slow water flow. There was no patient injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50815095 ↗
• MalfunctionSep 16, 2026Filling Problem

  A Field Service Engineer (FSE) was dispatched to the user facility for a separate issue. During the inspection of the Endoscope Reprocessor, the water flow into the reprocessing basin was found to be low. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50790181 ↗
• MalfunctionSep 15, 2026Filling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50780383 ↗
• MalfunctionSep 15, 2026Residue After Decontamination

  During onsite inspection of the Endoscope Reprocessor debris was found in the sensors. There was no patient injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776090 ↗
• MalfunctionSep 8, 2026Failure to Clean Adequately

  It was reported that the Endoscope Reprocessor had debris in the basin. The issue occurred during reprocessing. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674484 ↗
• MalfunctionSep 3, 2026Pressure Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50588998 ↗
• MalfunctionAug 31, 2026Infusion or Flow Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50529924 ↗
• MalfunctionAug 31, 2026Device Reprocessing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50528552 ↗
• MalfunctionAug 26, 2026Degraded

  No additional information from the customer.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50460804 ↗

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