SUCTION VALVERecalls & reported problems across all models
Olympus Medical Systems Corp. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one SUCTION VALVE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 5 models of SUCTION VALVE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Nov 28, 2018 and Jun 5, 2026 — classified as 1 injury, 31 malfunctions.
The most frequently reported specific device problem is “Device Reprocessing Problem” (11 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
SUCTION 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-1610-2026 · Root cause: Reprocessing Controls · Recall details · FDA record ↗
Most reported SUCTION VALVE problems
Device problems
- Device Reprocessing Problem11
- Microbial Contamination of Device10
- Detachment of Device or Device Component5
- Residue After Decontamination3
- Break2
- Defective Device2
- Failure to Clean Adequately2
- Product Quality Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- No Known Impact Or Consequence To Patient2
- Chest Pain1
- Ectopic Heartbeat1
- No Consequences Or Impact To Patient1
- Respiratory Insufficiency1
SUCTION VALVE models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SUCTION VALVE MAJ-1443Colonoscope and accessories, flexible/rigid1 recall0 reports
- SUCTION VALVE MAJ-207FORCEPS, BIOPSY, ELECTRIC13 reports
- Suction valve MH-443Gastroscope And Accessories, Flexible/Rigid12 reports
- Suction Valve MD-493Gastroscope And Accessories, Flexible/Rigid5 reports
- Suction Valve MD-493Gastroscope and accessories, flexible/rigid2 reports
Recent SUCTION VALVE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2026Residue After Decontamination
THE CUSTOMER REPORTED THE CLEANING BRUSH BRISTLES WERE CLOGGED IN THE SIDE HOLE OF THE SUCTION VALVE DURING A DIAGNOSTIC UPPER GASTROINTESTINAL ENDOSCOPY SCREENING. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25413475 ↗MalfunctionMar 19, 2025Residue After Decontamination; Residue After Decontamination
IT WAS REPORTED THE SUCTION VALVE HAD A SMALL GREEN FIBROUS FOREIGN MATERIAL THAT CAME OUT OF THE SUCTION BUTTON. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21643080 ↗MalfunctionFeb 19, 2025Residue After Decontamination; Residue After Decontamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUCTION VALVE EXHIBITED ADHESION OF FOREIGN MATERIAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21413805 ↗InjuryNov 18, 2024Break; Break
IT WAS REPORTED THAT THE SUCTION BUTTON/VALVE SUDDENLY BROKE AND COULD NOT BE REMOVED FROM THE ENDOSCOPE DURING A BRONCHOSCOPY PROCEDURE. AS SUCH, THE PROCEDURE/EXAMINATION WAS INTERRUPTED AND THE PATIENT PRESENTED WITH CHEST TIGHTNESS, RESPIRATORY INSUFFICIENCY AND ARRHYTHMIA. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH A SIMILAR DEVICE WITH A DELAY OF 20 MINUTES. FOLLOW-UP INFORMATION FOR THE EVENT IS PENDING AT THE TIME OF THE REPORT.
Patient problems: Chest Pain; Ectopic Heartbeat; Respiratory Insufficiency
MAUDE report 20707761 ↗MalfunctionAug 21, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SUCTION VALVE EXHIBITED A FOREIGN OBJECT CLOGGED IN THE LATERAL HOLE OF THE "S BUTTON". THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20014184 ↗MalfunctionJun 7, 2024Misassembled During Installation; Misassembled During Installation
IT WAS REPORTED THAT THE SUCTION VALVE WAS CONNECTED WHEN THE CONNECTING TUBE SHOULD HAVE BEEN USED. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF INFECTIONS OR PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19487961 ↗MalfunctionNov 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED TO OLYMPUS THAT THE SUCTION VALVE, HAD THE RUBBER RING REMAIN IN THE CONNECTION ON THE SCOPE. THE ISSUE OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS UNKNOWN. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18213668 ↗MalfunctionNov 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THE PRODUCT PROBLEM CAUSED A DELAY OF ABOUT 1.5 MINUTES. THE PROCEDURE WAS COMPLETED WITH NEW SUCTION VALVE. THERE WAS NO PROCEDURE POSTPONEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18186200 ↗MalfunctionNov 15, 2023Degraded; Fluid/Blood Leak; Loose or Intermittent Connection; Degraded; Fluid/Blood Leak; Loose or Intermittent Connection
THE CUSTOMER CONFIRMED EVENT OCCURRED DURING THE PROCEDURE. THE DEVICE WAS SWITCHED OUT FOR A NEW SUCTION VALVE MAJ-207 LOT NUMBER UNKNOWN. THERE WERE NO PROCEDURAL DELAYS. IT IS UNKNOWN IF THE PATIENT HAD ANY PRE-EXISTING CONDITIONS AT THE TIME OF THE EVENT. IT IS UNKNOWN IF THE DEVICE INSPECTED PRIOR TO USAGE. IT IS UNKNOWN IF THE PROCEDURE WAS THERAPEUTIC OR DIAGNOSTIC, AND THE PATIENT¿S CONDITION IS UNKNOWN. THERE WAS NO PROLONGED HOSPITAL STAY AND THE PATIENT WAS DISCHARGED AS PLANNED. NO FURTHER INFORMATION CAN BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18141943 ↗MalfunctionJul 24, 2023Device Reprocessing Problem; Microbial Contamination of Device; Device Reprocessing Problem; Microbial Contamination of Device
THE FOLLOWING PATIENT IDENTIFIERS ARE RELATED TO THIS EVENT: (B)(6), MD-493: SUCTION VALVE -1; (B)(6), MD-493: SUCTION VALVE -2; (B)(6), MD-493: SUCTION VALVE -3; (B)(6), MD-493: SUCTION VALVE -4; (B)(6), MD-493: SUCTION VALVE -5; (B)(6), MD-493: SUCTION VALVE -6; (B)(6), MD-493: SUCTION VALVE -7; (B)(6), LF-TP, SN (B)(6); (B)(6), LF-GP, SN (B)(6); (B)(6), LF-GP, SN (B)(6); (B)(6), LF-TP, SN (B)(6); (B)(6), LF-GP, SN (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17386270 ↗MalfunctionJul 24, 2023Device Reprocessing Problem; Microbial Contamination of Device; Device Reprocessing Problem; Microbial Contamination of Device
THE FOLLOWING PATIENT IDENTIFIERS ARE RELATED TO THIS EVENT: (B)(6), MD-493: SUCTION VALVE -1. (B)(6), MD-493: SUCTION VALVE -2. (B)(6), MD-493: SUCTION VALVE -3. (B)(6), MD-493: SUCTION VALVE -4. (B)(6), MD-493: SUCTION VALVE -5. (B)(6), MD-493: SUCTION VALVE -6. (B)(6), MD-493: SUCTION VALVE -7. (B)(6), LF-TP, SN (B)(6). (B)(6), LF-GP, SN (B)(6). (B)(6), LF-GP, SN (B)(6). (B)(6), LF-TP, SN (B)(6). (B)(6), LF-GP, SN (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17386083 ↗MalfunctionJul 24, 2023Device Reprocessing Problem; Microbial Contamination of Device; Device Reprocessing Problem; Microbial Contamination of Device
THE FOLLOWING PATIENT IDENTIFIERS ARE RELATED TO THIS EVENT: (B)(6), MD-493: SUCTION VALVE -1 (B)(6), MD-493: SUCTION VALVE -2 (B)(6), MD-493: SUCTION VALVE -3 (B)(6), MD-493: SUCTION VALVE -4 (B)(6), MD-493: SUCTION VALVE -5 (B)(6), MD-493: SUCTION VALVE -6 (B)(6), MD-493: SUCTION VALVE -7 (B)(6), LF-TP, SN (B)(6). (B)(6), LF-GP, SN (B)(6). (B)(6), LF-GP, SN (B)(6). (B)(6), LF-TP, SN (B)(6). (B)(6), LF-GP, SN (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17386064 ↗MalfunctionJul 24, 2023Device Reprocessing Problem; Microbial Contamination of Device; Device Reprocessing Problem; Microbial Contamination of Device
THE CUSTOMER REPORTED TO OLYMPUS THAT THE SUCTION VALVES WERE CONTAMINATED WITH STENOTROPHOMONAS MALTOPHILIA BACTERIA THAT OCCURRED DURING REPROCESSING. THERE WAS NO REPORT OF PATIENT INFECTION. ACCORDING TO THE REPORT, THE CONTAMINATION OCCURRED WHEN INADEQUATE REPROCESSING PROCEDURES WERE FOLLOWED. NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THIS EVENT. THIS EVENT REPORTED INVOLVED SEVEN SUCTION VALVES. THE SEVEN (7) SUCTION VALVE INVOLVED IN THIS EVENT (BACTERIAL CONTAMINATION) ARE REPORTED UNDER THE FOLLOWING PATIENT IDENTIFIERS: (B)(6). THIS REPORT BEING SUBMITTED IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17385962 ↗MalfunctionJul 24, 2023Device Reprocessing Problem; Microbial Contamination of Device; Device Reprocessing Problem; Microbial Contamination of Device
RELATED PATIENT IDENTIFIERS: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17385621 ↗MalfunctionJul 24, 2023Device Reprocessing Problem; Microbial Contamination of Device; Device Reprocessing Problem; Microbial Contamination of Device
THE FOLLOWING PATIENT IDENTIFIERS ARE RELATED TO THIS EVENT: (B)(6), MD-493: SUCTION VALVE -1. (B)(6), MD-493: SUCTION VALVE -2. (B)(6), MD-493: SUCTION VALVE -3. (B)(6), MD-493: SUCTION VALVE -4. (B)(6), MD-493: SUCTION VALVE -5. (B)(6), MD-493: SUCTION VALVE -6. (B)(6), MD-493: SUCTION VALVE -7. (B)(6), LF-TP, SN (B)(6). (B)(6), LF-GP, SN (B)(6). (B)(6), LF-GP, SN (B)(6). (B)(6), LF-TP, SN (B)(6). (B)(6), LF-GP, SN (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17379488 ↗
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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