ENDOSCOPE REPROCESSOR OER-ProRecalls & reported problems
Olympus Medical Systems Corp. · Class 2
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus OER-Pro is an endoscope reprocessor, a machine that cleans and disinfects endoscopes between uses. Many of its 1,157 reports describe breaks, cracks and reprocessing problems, and recent reports describe cleaning fluid not draining and damaged cables. The reports include 25 injuries and no deaths. Three open recalls name this device, covering endoscopes that are no longer compatible, maintenance warnings and labeling changes.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,163
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 1,163 adverse event reports that list this exact device (DI 04953170258589), received between Oct 3, 2019 and Sep 30, 2026 — classified as 29 injuries, 1,134 malfunctions.
The most frequently reported specific device problem is “Break” (316 reports).
3 FDA recall records name this device's identifier, 3 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- 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 · FDA record ↗
- 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 · FDA record ↗
- 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 · FDA record ↗
Most reported problems
Device problems
- Break316
- Crack224
- Device Reprocessing Problem149
- Connection Problem95
- Detachment of Device or Device Component36
- Fluid/Blood Leak25
- Contamination23
- Failure to Clean Adequately23
Patient problems
- No Clinical Signs, Symptoms or Conditions825
- No Patient Involvement284
- No Consequences Or Impact To Patient26
- Viral Infection5
- Dizziness4
- Headache4
- Sepsis4
- Sexually Transmitted Infection4
Recent adverse event reports
The 25 most recent of 1,163 reports, 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 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 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 ↗MalfunctionAug 24, 2026Infusion or Flow Problem
The customer reported that the Endoscope Reprocessor exhibited an issue in which the cleaning fluid was not drained from the basin during reprocessing. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50411801 ↗MalfunctionJul 27, 2026Failure to Disinfect
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50008952 ↗MalfunctionJun 1, 2026Filling Problem; Decrease in Pressure
IT WAS REPORTED THAT, DURING REPROCESSING, THE ENDOSCOPE REPROCESSOR HAD A PRESSURE DROP ACROSS THE SECOND IN-LINE FILTER FROM 50 POUNDS PER SQUARE INCH (PSI) TO 15 PSI. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25354527 ↗MalfunctionMay 28, 2026Failure to Clean Adequately
IT WAS REPORTED THE TUB FLUID LEVEL SENSOR AND FLOAT SENSOR IN THE ENDOSCOPE REPROCESSOR WAS DIRTY. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25320265 ↗MalfunctionMay 26, 2026Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE ENDOSCOPE REPROCESSOR EXHIBITED DAMAGE TO THE CABLE END ON THE SIDE CONNECTING TO THE REPROCESSOR, INCLUDING ONE MISSING SCREW PIN. THE ISSUE WAS IDENTIFIED DURING REPROCESSING AND THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25283821 ↗MalfunctionMay 22, 2026Contamination
A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE USER FACILITY FOR A SEPARATE ISSUE. DURING THE INSPECTION OF THE OER-PRO, THERE WAS DEBRIS FOUND IN THE PRESSURE REGULATOR TUBING. THE FSE REPORTED AFTER THE DEBRIS WAS REMOVED, THE OER-PRO WORKED AS INTENDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25259937 ↗MalfunctionMay 19, 2026Device Reprocessing Problem; Activation Failure
IT WAS REPORTED THAT THE ENDOSCOPE REPROCESSOR EXHIBITED PROLONGED REPROCESSING CYCLE TIMES. DURING THE CYCLE, THE DEVICE REMAINED AT 17 MINUTES FOR AN EXTENDED PERIOD BEFORE COMPLETING THE CYCLE NEAR THE END. THE ISSUE WAS REPORTEDLY OBSERVED FOLLOWING REPLACEMENT OF THE DISINFECTANT ALCOHOL AND DURING THE FIRST CYCLE OF THE DAY. THE ISSUE OCCURRED DURING REPROCESSING AND THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25220794 ↗MalfunctionApr 30, 2026Failure to Clean Adequately
IT WAS WAS REPORTED THAT THE ENDOSCOPE REPROCESSOR EXHIBITED THE DEVICE SENSOR WAS COVERED WITH DEBRIS, A FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE AND THE DEVICE WAS CLEANED AND RECONNECTED THEN TESTED THE DEVICE AND RETURNED TO SERVICE. THE EVENT OCCURRED AT REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25044933 ↗MalfunctionApr 23, 2026Ejection Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24967355 ↗MalfunctionApr 23, 2026Device Reprocessing Problem
NO ADDITIONAL INFORMATION FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24965898 ↗MalfunctionApr 17, 2026Device Reprocessing Problem
NO NEW INFORMATION RECEIVED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24915615 ↗MalfunctionApr 17, 2026Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE TUB SENSOR OF THE ENDOSCOPE REPROCESSOR HAD DEBRIS ON IT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24909889 ↗MalfunctionMar 23, 2026Residue After Decontamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE REPROCESSOR HAD DRIED RESIDUE ON THE INSIDE FLOOR OF THE REPROCESSING BASIN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24660892 ↗MalfunctionMar 11, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BROKEN GRAY SCOPE CONNECTOR OF THE REPROCESSOR HAD COME APART. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24571259 ↗MalfunctionMar 6, 2026Detachment of Device or Device Component
IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE REPROCESSOR IS MISSING A TORIC/PACKING JOINT IN THE HOSE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24539290 ↗MalfunctionFeb 25, 2026Device Reprocessing Problem
NO ADDITIONAL INFORMATION FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24443657 ↗MalfunctionFeb 25, 2026Component Missing
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE REPROCESSOR TANK HAD A MISSING O-RING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24443429 ↗MalfunctionFeb 24, 2026Degraded
IT WAS REPORTED THAT DURING DEVICE EVALUATION, THE WATER FILTER OF THE ENDOSCOPE REPROCESSOR WAS OUT OF DATE RANGE FOR FILTER CHANGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24431413 ↗MalfunctionFeb 20, 2026Infusion or Flow Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ENDOSCOPE REPROCESSOR EXHIBITED FLOW PROBLEM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24401832 ↗
Other ACCESSORIES, CLEANING, FOR ENDOSCOPE devices
- ENDOSCOPE REPROCESSOR OER-EliteOlympus Medical Systems Corp. · Accessories, cleaning, for endoscope4 recalls323 reports
- SINGLE USE DISTAL COVER MAJ-2315Olympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope2 recalls294 reports
- CONNECTING TUBE MAJ-2110Olympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope1 recall213 reports
- CONNECTING TUBE MAJ-2111Olympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope1 recall164 reports
- CONNECTING TUBE MAJ-2113Olympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope1 recall159 reports
- CONNECTING TUBE MAJ-2112Olympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope1 recall143 reports
- ENDOSCOPE REPROCESSOR OER-MINIOlympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope2 recalls11 reports
- Medivators HookupMedivators Inc. · Accessories, cleaning, for endoscope2 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.