AIR/WATER VALVERecalls & reported problems across all models
Olympus Medical Systems Corp. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one AIR/WATER VALVE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 62
- Deaths reported
- 1
- Injuries reported
- 2
- Recalls
- 2
We found 3 models of AIR/WATER VALVE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 62 adverse event reports in the FDA's MAUDE database, received between Nov 28, 2018 and Feb 11, 2026 — classified as 1 death, 2 injuries, 59 malfunctions.
The most frequently reported specific device problem is “Contamination” (16 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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
AIR/WATER VALVE 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.
- 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-1611-2026 · Root cause: Reprocessing Controls · Recall details · FDA record ↗
- Jul 12, 2023Open, Classified
The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure.
Z-2447-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported AIR/WATER VALVE problems
Device problems
- Contamination16
- Device Reprocessing Problem14
- Failure to Clean Adequately14
- Crack7
- Device Contamination with Body Fluid4
- Microbial Contamination of Device4
- Restricted Flow rate2
- Use of Device Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions59
- No Known Impact Or Consequence To Patient2
- Death1
AIR/WATER VALVE models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AIR/WATER VALVE MAJ-1444Endoscope, accessories, narrow band spectrum2 recalls41 reports
- Air/water valve MH-438Endoscopic video imaging system/component, gastroenterology-urology1 death15 reports
- AIR/WATER VALVE MAJ-1444Endoscope, accessories, narrow band spectrum6 reports
Recent AIR/WATER VALVE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2026Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE AIR/WATER VALVE EXHIBITED CORROSION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24314037 ↗MalfunctionNov 21, 2025Material Integrity Problem; Material Integrity Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE AIR/WATER VALVE'S SEALS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23624908 ↗MalfunctionOct 30, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS REPORTED THAT THE AIR/WATER VALVE WAS INSUFFICIENTLY /INCORRECTLY REPROCESSED. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20571562 ↗MalfunctionOct 30, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS REPORTED THAT THE AIR/WATER VALVE WAS INSUFFICIENTLY /INCORRECTLY REPROCESSED. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20571506 ↗MalfunctionOct 30, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS REPORTED THAT THE AIR/WATER VALVE WAS INSUFFICIENTLY /INCORRECTLY REPROCESSED. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20571385 ↗MalfunctionSep 6, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED, THAT THE AIR/WATER VALVE EXHIBITED A WATER LEAKAGE FROM THE BALLOON OF THE GASTROVIDEOSCOPE. AND THE AIR/WATER VALVE WAS REPLACED AND THE PROBLEM WAS RESOLVED. THE ISSUE WAS FOUND, DURING PREPARATION FOR USE. FOR AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20158488 ↗MalfunctionJun 18, 2024Device Contamination with Body Fluid; Failure to Clean Adequately; Device Contamination with Body Fluid; Failure to Clean Adequately
IT WAS REPORTED THAT THE AIR/WATER VALVE WAS USED IN A CASE WITH HEAVY BLEEDING, THOROUGHLY CLEANED WITH THE ENDOSCOPE REPROCESSOR, AND STORED. THE NEXT DAY, BEFORE A PROCEDURE, BLOOD WAS NOTICED DRIPPING FROM THE AIR/WATER NOZZLE OF THE GASTROVIDEOSCOPE. THE ISSUE OCCURRED DURING PREPARATION BEFORE USE FOR AN UNSPECIFIED PROCEDURE WHICH WAS COMPLETED USING ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19559401 ↗MalfunctionJun 18, 2024Device Contamination with Body Fluid; Failure to Clean Adequately; Device Contamination with Body Fluid; Failure to Clean Adequately
IT WAS REPORTED THAT THE AIR/WATER VALVE WAS USED IN A CASE WITH HEAVY BLEEDING, THOROUGHLY CLEANED WITH THE ENDOSCOPE REPROCESSOR, AND STORED. THE NEXT DAY, BEFORE A PROCEDURE, BLOOD WAS NOTICED DRIPPING FROM THE AIR/WATER NOZZLE OF THE GASTROVIDEOSCOPE. THE ISSUE OCCURRED DURING PREPARATION BEFORE USE FOR AN UNSPECIFIED PROCEDURE WHICH WAS COMPLETED USING ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19559377 ↗MalfunctionJun 17, 2024Device Contamination with Body Fluid; Failure to Clean Adequately; Device Contamination with Body Fluid; Failure to Clean Adequately
IT WAS REPORTED THAT THE AIR/WATER VALVE WAS USED IN A CASE WITH HEAVY BLEEDING, THOROUGHLY CLEANED WITH THE ENDOSCOPE RE-PROCESSOR, AND STORED. THE NEXT DAY, BEFORE A PROCEDURE, BLOOD WAS NOTICED DRIPPING FROM THE AIR/WATER NOZZLE OF THE GASTROVIDEOSCOPE. THE ISSUE OCCURRED DURING PREPARATION BEFORE USE INSPECTION FOR AN UNSPECIFIED PROCEDURE WHICH WAS COMPLETED USING ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19547899 ↗MalfunctionJun 13, 2024Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED THAT WHEN THE AIR/WATER VALVE WAS USED WITH THE GF-UCT260, BLOOD STARTED DRIPPING FROM THE AIR/WATER NOZZLE. THE ISSUE OCCURRED DURING PREPARATION BEFORE USE INSPECTION FOR AN UNSPECIFIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF DELAYS. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19533359 ↗MalfunctionJun 4, 2024Break; Break
IT WAS REPORTED, DURING REPROCESSING, A PIECE OF BROKEN PACKING FROM THE AIR/WATER VALVE FLOATED OUT OF THE WATER. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19461787 ↗MalfunctionDec 11, 2023Failure to Clean Adequately; Failure to Clean Adequately
THE CUSTOMER REPORTED TO OLYMPUS, DURING A DIAGNOSTIC ENDOSCOPY PROCEDURE THEIR AIR/ WATER VALVE HAD THE FOLLOWING CONCERN; THE AIR/WATER SUPPLY BUTTON COULD NOT BE OPERATED. THE DEVICE WAS RETURNED FOR EVALUATION AND DURING THE EVALUATION IT WAS DETERMINED THAT THE FOLLOWING REPORTABLE EVENTS WERE IDENTIFIED; FOREIGN MATERIAL WAS ON THE AIR/ WATER SUPPLY BUTTON. THERE WAS NO PATIENT HARM, PROCEDURAL DELAY, OR INJURY AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. RELATED PATIENT IDENTIFIERS: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18301413 ↗MalfunctionSep 15, 2023Lack of Maintenance Documentation or Guidelines; Lack of Maintenance Documentation or Guidelines
THE CUSTOMER REPORTED TO OLYMPUS THAT THE INSTRUCTION MANUAL FOR THE ULTRASONIC ENDOSCOPE HAS DESCRIPTION ABOUT THE INSPECTION OF THE AIR/WATER VALVE; HOWEVER, THERE WAS NO DESCRIPTION OF THE PASS/FAIL JUDGEMENT DUE TO WHICH IT WAS NOT POSSIBLE TO JUDGE THE EXTENT OF ALLOWABLE RANGE. THE CUSTOMER REQUESTED GUIDELINE FOR INSPECTION. THIS COMPLAINT IS BEING SUBMITTED TO CAPTURE THE ALLEGATION OF INSUFFICIENT INSPECTION GUIDELINE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17754848 ↗MalfunctionSep 14, 2023Device Reprocessing Problem; Device Reprocessing Problem
THE CUSTOMER REPORTED THAT FOLLOWING A COMPLETED REPROCESSING CYCLE WITH HIS OLYMPUS AIR/WATER VALVE, HE PRESSED ONE OF THE BUTTONS AND A TRANSPARENT FIBROUS MATERIAL CAME OUT FROM THE SPRING. THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17744145 ↗MalfunctionAug 25, 2023Device Reprocessing Problem; Device Reprocessing Problem
THE CUSTOMER REPORTED THAT WHILE HIS MEDICAL STAFF WAS WASHING AFTER AN EUS-FNA TEST, A THIN RED OBJECT CAME OUT FROM THE TIP OF HIS OLYMPUS AIR/WATER VALUE. REPORTEDLY, AFTER THAT, A RED-BROWN OBJECT APPEARED ALSO. AS THIS WAS DISCOVERED FOLLOWING THE COMPLETION OF THE PROCEDURE, THIS EVENT HAD NO IMPACT ON THE PATIENT OF THIS CASE. WHILE PERFORMING DILIGENCE CONCERNING THIS EVENT, IT BECAME CLEAR THAT THE USER FACILITY HAD BEEN INSUFFICIENTLY REPROCESSING SOME OF THEIR OLYMPUS DEVICES. THIS REPORT IS 6 OF 14 BEING SUBMITTED TO CAPTURE THE SERIES OF INSUFFICIENTLY REPROCESSED DEVICES BY THE SAME USER FACILITY. FOR THE RELATED FILES, PLEASE SEE REPORTS WITH PATIENT IDENTIFIERS: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17623324 ↗
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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