WATER FILTERRecalls & reported problems across all models
Olympus Medical Systems Corp. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one WATER FILTER model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 40
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of WATER FILTER by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 40 adverse event reports in the FDA's MAUDE database, received between Mar 22, 2023 and Feb 13, 2026 — classified as 40 malfunctions.
The most frequently reported specific device problem is “Device Reprocessing Problem” (25 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 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
WATER FILTER 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.
- 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 WATER FILTER problems
Device problems
- Device Reprocessing Problem25
- Improper or Incorrect Procedure or Method12
- 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 Conditions40
WATER FILTER models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- WATER FILTER MAJ-2318Accessories, Cleaning, For Endoscope1 recall33 reports
- WATER FILTER MAJ-824ACCESSORIES, CLEANING, FOR ENDOSCOPE7 reports
Recent WATER FILTER adverse event reports
The 15 most recent reports across all models, 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 ↗
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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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