WATER FILTER MAJ-2318Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of WATER FILTER (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus water filter is used in endoscope reprocessing, the process that cleans and disinfects reusable scopes between patients. The 33 reports mostly describe the filter not being replaced on schedule, being put together incorrectly, or restricting water flow, all during reprocessing; none report patient harm, deaths or injuries. There is 1 open recall, started in January 2024, because the filter may have been assembled incorrectly, letting unfiltered tap water contact the scope and potentially exposing patients to infection.
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
- 33
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 04953170401473), received between Apr 10, 2023 and Feb 13, 2026 — classified as 33 malfunctions.
The most frequently reported specific device problem is “Device Reprocessing Problem” (20 reports).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (K190969); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Recalls naming this device
- Jan 16, 2024Open, Classified
Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used for reprocessing. This may expose a patient to a potentially contaminated device, presenting a risk of infection or sepsis.
Z-1009-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Reprocessing Problem20
- Improper or Incorrect Procedure or Method11
- Failure to Clean Adequately2
- Product Quality Problem2
- Restricted Flow rate2
- Use of Device Problem2
- Communication or Transmission Problem1
- Filtration Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions33
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 13, 2026Device Reprocessing Problem; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT, DURING REPROCESSING, THE WATER FILTER HAD BEEN USED CLINICALLY WITHOUT BEING REPLACED FOR A LONG PERIOD OF TIME. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24337419 ↗MalfunctionFeb 11, 2026Improper or Incorrect Procedure or Method
IT WAS REPORTED THE ENDOSCOPE REPROCESSOR WATER FILTER REPLACEMENT PERIOD MAY BE OUTSIDE THE RECOMMENDED OPERATING RANGE, DUE TO THE EXTREMELY LOW NUMBER OF CASES AT THE FACILITY, ALL FILTERS ARE REPLACED ONCE A YEAR. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24313459 ↗MalfunctionJan 8, 2026Device Reprocessing Problem; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE SCOPE WAS REPROCESSED INCORRECTLY BECAUSE THE WATER FILTER IN THE ENDOSCOPE REPROCESSOR WAS USED EXCESSIVELY WITHOUT REPLACEMENT FOR AN EXTENDED PERIOD, FROM (B)(6) 2025 TO (B)(6) 2025. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24001779 ↗MalfunctionJan 6, 2026Device Reprocessing Problem; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE WATER FILTER REPLACEMENT ON THE ENDOSCOPE REPROCESSOR WAS NOT PERFORMED PROPERLY. THE CUSTOMER STATED THAT THEY WERE NOT AWARE OF REQUIREMENT FOR THE WATER FILTER INSPECTION. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23975755 ↗MalfunctionDec 23, 2025Device Reprocessing Problem; Device Reprocessing Problem
NO NEW INFORMATION RECEIVED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23877250 ↗MalfunctionNov 26, 2025Device Reprocessing Problem; Improper or Incorrect Procedure or Method; Device Reprocessing Problem; Improper or Incorrect Procedure or Method
IT WAS REPORTED THE WATER FILTER HAD NOT BEEN REPLACED IN 2 YEARS. THE REPORTED ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23658624 ↗MalfunctionNov 25, 2025Device Reprocessing Problem; Improper or Incorrect Procedure or Method; Device Reprocessing Problem; Improper or Incorrect Procedure or Method
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23652348 ↗MalfunctionNov 12, 2025Device Reprocessing Problem; Device Reprocessing Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23531486 ↗MalfunctionJul 29, 2025Device Reprocessing Problem; Improper or Incorrect Procedure or Method; Device Reprocessing Problem; Improper or Incorrect Procedure or Method
IT WAS REPORTED, THAT THE WATER FILTER WAS NOT REPLACED IN A LONG TIME IN THE REPROCESSOR RESULTING IN ENDOSCOPE BEING WASHED OVER TIME AND USED ON PATIENTS. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22645586 ↗MalfunctionMay 20, 2025Device Reprocessing Problem; Improper or Incorrect Procedure or Method; Device Reprocessing Problem; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE WATER FILTER FOR THE REPROCESSOR WAS REPLACED EVERY SIX MONTHS INSTEAD OF THE REGULAR ONE. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22056788 ↗MalfunctionMay 19, 2025Device Reprocessing Problem; Improper or Incorrect Procedure or Method; Device Reprocessing Problem; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE REPROCESSOR WATER FILTER HAD NOT BEEN CHANGED AT THE APPROPRIATE INTERVALS AND WAS USED TO REPROCESS DEVICES. THERE WERE NO REPORTS OF PATIENT OR USER HARM AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22043264 ↗MalfunctionMay 16, 2025Device Reprocessing Problem; Improper or Incorrect Procedure or Method; Device Reprocessing Problem; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE WATER FILTER FOR THE REPROCESSING UNIT HAD NOT BEEN CHANGED AT THE APPROPRIATE INTERVALS, AND THE SCOPE WASHED BY REPROCESSOR WAS USED ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22037972 ↗MalfunctionOct 30, 2024Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED THE WATER FILTER WASN'T CHANGED FOR 5 YEARS. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20575419 ↗MalfunctionOct 29, 2024Filtration Problem; Filtration Problem
IT WAS REPORTED, THAT THE OER-PRO INTERNAL WATER FILTER WAS NOT LASTING LONG. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20557491 ↗MalfunctionOct 25, 2024Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED THAT THE WATER FILTER HAD DECREASED IN FLOW RATE AFTER IT WAS REPLACED. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20533462 ↗MalfunctionOct 10, 2024Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED THE INTERNAL WATER FILTER WAS CLOGGED, THE CUSTOMER THOUGHT THEY HAD ORDERED THE WRONG FILTER BUT IT WAS CONFIRMED THAT IT WAS THE CORRECT ONE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20418567 ↗MalfunctionOct 9, 2024Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT THE WATER FILTER WAS ORDERED FROM CUSTOMER AND ORDER WAS RECEIVED WITH CORRECT LABELING ON OUTSIDE BUT WHEN BOX IS OPENED IT CONTAINS PALL CORP RA154500 AND IT DID NOT FIT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20408114 ↗MalfunctionOct 9, 2024Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT THE WATER FILTER WAS ORDERED FROM CUSTOMER AND ORDER WAS RECEIVED WITH CORRECT LABELING ON OUTSIDE BUT WHEN BOX IS OPENED IT CONTAINS PALL CORP RA154500 AND IT DID NOT FIT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20406824 ↗MalfunctionOct 2, 2024Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED AN E16 ERROR OCCURRED WHILE USING THE WATER FILTER AND ENDOSCOPE REPROCESSOR. ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE EVENT STATING THE WATER FILTER WAS OVERDUE FOR REPLACEMENT, FAILURE TO DISINFECT THE WATER SUPPLY PIPELINES AND ACECIDE CONCENTRATION TESTING WAS NOT PERFORMED. THE ISSUE OCCURRED DURING REPROCESSING WITH NO REPORTS OF PATIENT HARM OR INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20354950 ↗MalfunctionSep 25, 2024Device Reprocessing Problem; Device Reprocessing Problem
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE WATER FILTER WAS NOT REPLACED AS INSTRUCTED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20304775 ↗MalfunctionSep 16, 2024Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS AN ERROR MESSAGE OCCURRED (ERROR E16) DURING REPROCESSING OF THE WATER FILTER. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20224846 ↗MalfunctionSep 12, 2024Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED THAT DEBRIS CAME FROM TUBING ABOVE THE WATER FILTER AFTER WATER FILTER CHANGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20205740 ↗MalfunctionSep 12, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THE WATER FILTER HAD NOT BEEN REPLACED SINCE (B)(6) 2022. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20200882 ↗MalfunctionAug 5, 2024Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED THE WATER FILTER HAD AN E01 ERROR (WATER SUPPLY INSUFFICIENCY ERROR) OCCUR ONE MINUTE BEFORE THE END OF THE CLEANING PROCESS. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19907119 ↗MalfunctionJul 26, 2024Device Reprocessing Problem; Communication or Transmission Problem; Device Reprocessing Problem; Communication or Transmission Problem
IT WAS REPORTED THAT DURING REPROCESSING THE WATER FILTER, AN ERROR CODE E01 OCCURRED ONE MINUTE BEFORE THE END OF THE CLEANING PROCESS. THE CAMERA THAT WAS BEING CLEANED AND THEN RINSED WITH WATER. THIS INCIDENT LED TO THE FACILITY CHANGING THE WATER FILTERS ONCE A YEAR .THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19838069 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K190969. One submission often covers many models, so check the product and lot details in each record.
- Z-0638-2022 · Dec 13, 2021 · TerminatedOER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessor
Other Accessories, Cleaning, For Endoscope devices
- ENDOSCOPE REPROCESSOR OER-ProOlympus Medical Systems Corp. · ACCESSORIES, CLEANING, FOR ENDOSCOPE3 recalls1,163 reports
- 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
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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