ENDOSCOPE REPROCESSOR OER-EliteRecalls & reported problems

Summary

The FDA's MAUDE database contains 323 adverse event reports that list this exact device (DI 04953170404047), received between Jan 13, 2021 and Sep 29, 2026 — classified as 9 injuries, 314 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (73 reports).

4 FDA recall records name this device's identifier, 3 still open.

12 other recalls cover devices cleared under the same FDA submission (K201920); they may or may not involve this specific model.

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.

Recalls naming this device

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

2. 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 · FDA record ↗

3. 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 · FDA record ↗

4. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 323 reports, in the reporter's own words as published by the FDA.

• 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 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 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 ↗
• MalfunctionAug 25, 2026Improper Flow or Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50435790 ↗
• MalfunctionAug 18, 2026Residue After Decontamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50309214 ↗
• MalfunctionAug 10, 2026Insufficient Flow or Under Infusion; Pressure Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50195346 ↗
• MalfunctionJul 28, 2026Infusion or Flow Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50057509 ↗
• MalfunctionJul 17, 2026Infusion or Flow Problem

  THE FIELD SERVICE ENGINEER REPORTED THE DRAIN HOSE WAS FAR DOWN THE DRAINPIPE AND THIS MAY HAVE CAUSED A VACUUM EFFECT. THIS EVENT OCCURRED DURING REPROCESSING INVOLVING AN OLYMPUS REPROCESSOR. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25861077 ↗
• MalfunctionJul 17, 2026Device Reprocessing Problem

  THE FIELD SERVICE ENGINEER REPORTED THE SURFACE OF THE CLEANING BASIN WAS VERY DIRTY WITH WHAT APPEARED TO BE MOLD GROWING. THIS EVENT OCCURRED DURING SERVICE AND MAINTENANCE INVOLVING AN OLYMPUS ENDOSCOPE REPROCESSOR. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25860896 ↗
• MalfunctionJun 22, 2026Blocked Connection; No Flow

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25588417 ↗
• MalfunctionJun 15, 2026Break

  A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE USER FACILITY TO PERFORM ANNUAL PREVENTIVE MAINTENANCE. DURING THE INSPECTION, IT WAS OBSERVED THAT THE ENDOSCOPE REPROCESSOR EXHIBITED A DAMAGED RETAINING RACK PIN LOCATED WITHIN THE CONNECTOR. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25512104 ↗
• MalfunctionJun 12, 2026Insufficient Flow or Under Infusion

  THE CUSTOMER RETURNED THE ENDOSCOPE REPROCESSOR TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPORT TECHNICIAN INDICATES THAT REDUCED WATER FLOW AND EXTENDED CYCLE TIMES WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25488784 ↗
• MalfunctionJun 1, 2026Filling Problem

  THE GASTROINTESTINAL VIDEOSCOPE WAS INSPECTED AT CUSTOMER SITE FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, A REPORTABLE EVENT WAS FOUND. IT WAS DETERMINED AS PART OF THE COMPLETED INVESTIGATION THAT 50 POUNDS PER SQUARE INCH WAS CONSIDERED LOW INCOMING WATER FLOW. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25351817 ↗
• MalfunctionMay 28, 2026Device Reprocessing Problem

  IT WAS REPORTED THAT, DURING REPROCESSING, THE ENDOSCOPE REPROCESSOR REPROCESSING TIME WAS 40 MINUTES EVEN AFTER REPLACING THE FILTER AND THE VALVE MAY STILL HAVE DEBRIS FROM LAST MONTH'S WATER HEATER EXCHANGE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25316762 ↗
• MalfunctionMay 28, 2026Filling Problem

  IT WAS REPORTED THAT, DURING SERVICE, THE ENDOSCOPE REPROCESSOR COULD NOT DETECT THE FLOW OF DETERGENT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25316596 ↗
• MalfunctionMay 19, 2026Improper Flow or Infusion

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ENDOSCOPE REPROCESSOR HAD POOR WATER FLOW. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216799 ↗
• MalfunctionMay 15, 2026Infusion or Flow Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE REPROCESSOR HAD A DECREASED WATER FLOW. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25187166 ↗
• MalfunctionMay 13, 2026Electrical /Electronic Property Problem; Operating System Version or Upgrade Problem

  IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT ENDOSCOPE REPROCESSOR EXHIBITED IMPROPER DETERGENT AGENT SENSOR FUNCTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163677 ↗
• MalfunctionMay 12, 2026Filling Problem

  AN OLYMPUS FIELD SERVICE ENGINEER (FSE) REPORTED THAT DURING AN ONSITE INSPECTION OF THE ENDOSCOPE REPROCESSOR, THE WATER FILTER HAD A LOW PRESSURE READING BELOW 17 PSI DURING THE RINSE CYCLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150930 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201920. One submission often covers many models, so check the product and lot details in each record.

• Z-1905-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.
• Z-1901-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
• Z-1902-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
• Z-1903-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
• Z-1900-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
• Z-1899-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111
• Z-1906-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
• Z-1904-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
• Z-1907-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
• Z-1908-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
• Z-1909-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.
• Z-1898-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.