ERBEFLO CleverCapRecalls & reported problems across all models
Erbe Medical, LLC · 8 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name at least one ERBEFLO CleverCap model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 2
We found 8 models of ERBEFLO CleverCap by Erbe Medical, LLC in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between Sep 26, 2024 and Sep 9, 2026 — classified as 1 injury, 36 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (31 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
ERBEFLO CleverCap 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.
- Mar 31, 2026Class IIOpen, Classified
Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
Z-2063-2026 · Root cause: Component change control · names 2 of these models · Recall details · FDA record ↗
- Mar 31, 2026Class IIOpen, Classified
Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
Z-2062-2026 · Root cause: Component change control · names 6 of these models · Recall details · FDA record ↗
Most reported ERBEFLO CleverCap problems
Device problems
- Leak/Splash31
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Insufficient Information1
- Low Oxygen Saturation1
ERBEFLO CleverCap models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ERBEFLO CleverCap® 20325-239Pump, Air, Non-Manual, For Endoscope1 recall24 reports
- ERBEFLO CleverCap® 20325-206Pump, Air, Non-Manual, For Endoscope1 recall5 reports
- ERBEFLO CleverCap® 20325-240Pump, Air, Non-Manual, For Endoscope1 recall3 reports
- ERBEFLO CleverCap® 20325-248Pump, Air, Non-Manual, For Endoscope1 recall3 reports
- ERBEFLO CleverCap® 20325-207Pump, Air, Non-Manual, For Endoscope1 recall1 report
- ERBEFLO CleverCap® 20325-208Pump, Air, Non-Manual, For Endoscope1 recall1 report
- ERBEFLO CleverCap® 20325-201Endoscopic Irrigation/Suction System1 recall0 reports
- ERBEFLO CleverCap® 20325-203Endoscopic Irrigation/Suction System1 recall0 reports
Recent ERBEFLO CleverCap adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Leak/Splash
It was reported that Hybrid CO2 Tubing/Cap Sets for Olympus® Scopes & CO2 leaked at the distal end prior to endoscopic procedures. No other information was provided regarding any other accessory used in the procedure. Specifically, it was reported that there was an unintended flow at the distal end of scopes prior to inserting a scope into a patient. There was no report of any patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50688526 ↗MalfunctionJun 18, 2026Leak/Splash
IT WAS REPORTED THAT SOMETIMES THE HYBRID CO2 TUBING/CAP SETS FOR FUJIFILM® LEAK FROM THE IRRIGATION LINE AND SCOPE BUTTONS WHEN CO2 IS ACTIVATED AND IRRIGATION IS INACTIVE. THE SETS ARE BEING USED WITH AN ERBE CO2 INSUFFLATOR [MODEL ECO 2 PLUS, PART NUMBER (P/N) 2N100-068, SERIAL NUMBER (S/N) INFORMATION NOT PROVIDED (NI); ERBE IRRIGATION PUMP (MODEL EIP 2, P/N 10325-000, S/N NI); FUJIFILM® SCOPE (P/N NI, SN NI), AND FUJI DISPOSABLE BUTTONS (P/N NI, LOT NUMBER NI). WHEN THE SET IS CHANGED, THE ISSUE IS RESOLVED. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25547991 ↗MalfunctionJun 18, 2026Leak/Splash
IT WAS REPORTED THAT THE HYBRID CO2 TUBING/CAP SETS FOR FUJIFILM® CONSISTENTLY AND STEADILY LEAKED FROM THE DISTAL END OF THE SCOPE. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25547900 ↗MalfunctionJun 8, 2026Leak/Splash
IT WAS REPORTED THAT THE HYBRID CO2 TUBING/CAP SET FOR PENTAX® LEAKED FROM THE IRRIGATION LINE. NO INFORMATION WAS PROVIDED IN REGARDS TO THE EQUIPMENT OR ANY OTHER ACCESSORY USED WHEN THE SET LEAKED. THERE WAS NO REPORT OF ANY PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25434081 ↗MalfunctionJun 1, 2026Leak/Splash
IT WAS REPORTED THAT THE HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS® SCOPES & CO2 LEAKED FROM THE DISTAL END OF THE SCOPE. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25350528 ↗MalfunctionMay 27, 2026Leak/Splash
IT WAS REPORTED THAT THE HYBRID CO2 TUBING/CAP SET FOR OLYMPUS® SCOPES & CO2 LEAKED FROM THE DISTAL END OF THE SCOPE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD). THE SET WAS USED WITH A BOSTON SCIENTIFIC PORT CONNECTOR. DURING THE PROCEDURE, THE PATIENTS O2 LEVEL DROPPED; THEREFORE, THEY WERE INTUBATED. NO DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE O2 LEVEL TO DROP. NEVERTHELESS, AT SOME POINT, THE PATIENT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL.
Patient problems: Low Oxygen Saturation
MAUDE report 25303575 ↗MalfunctionMay 19, 2026Leak/Splash
IT WAS REPORTED THAT A HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS® SCOPES LEAKED FROM THE TUBING AT THE DISTAL DURING STANDARD ENDOSCOPY. ADDITIONALLY, IT WAS STATED THAT IF THE SETS ARE USED WITH ERBE'S PORT CONNECTOR THEN THE SETS DON'T LEAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25221856 ↗MalfunctionMay 18, 2026Leak/Splash
IT WAS REPORTED THAT THE HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS® SCOPES & CO2 INTERMITTENTLY OVER THE PAST 4 WEEKS, THERE IS A CONTINUOUS IRRIGATION STREAM. PHYSICIANS HAVE COMPLAINED ABOUT IT DURING PROCEDURES THAT IT DISTORTS THEIR VISUALIZATION. THE STAFF HAVE COMPLAINED THAT IT WILL LEAK FROM DISTAL END OF SCOPE WHILE WAITING FOR PROCEDURE TO START. OTHER LOT NUMBERS OF THE SAME PART NUMBER [LOT NUMBER (L/N) W4468274, DATE OF MANUFACTURING (DOM) 09/11/25, AND EXPIRATION DATE (EXP. DATE) 09/10/28; L/N W4468275, DOM 09/11/25, AND EXP. DATE 09/10/28; L/N WO469444, DOM 09/25/25, AND EXP. DATE 09/24/28; AND L/N WO469448, DOM 09/25/25, AND EXP. DATE 09/24/28] WERE ALSO A PART OF THE COMPLAINT. THERE WERE NO REPORTS OF ANY PATIENT INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25199384 ↗MalfunctionMay 14, 2026Leak/Splash
IT WAS REPORTED THAT THE HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS® SCOPES & UCR LEAKED FROM THE DISTAL END OF THE SCOPES ONCE THE PHYSICIAN REMOVES THEIR FOOT FROM THE IRRIGATION PUMP'S FOOTSWITCH PEDAL. ANOTHER LOT NUMBER OF THE SAME PART NUMBER (LOT NUMBER WO473172, DATE OF MANUFACTURING 11/06/25, AND EXPIRATION DATE 11/05/28) WAS ALSO A PART OF THE COMPLAINT. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25177139 ↗MalfunctionMay 12, 2026Leak/Splash
IT WAS REPORTED THAT A HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS® SCOPES LEAKED FROM THE TUBING AT THE DISTAL. THE SETS WERE USED WITH A BOSTON SCIENTIFIC PORT CONNECTOR. SPECIFICALLY, IT WAS REPORTED THAT "SOMETIMES AN EXTRA LEAK OF FLUID THAT WILL SPONTANEOUSLY LEAK FROM SCOPE DURING PROCEDURES".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25147443 ↗MalfunctionMay 4, 2026Leak/Splash
IT WAS REPORTED THAT THE HYBRID CO2 TUBING/CAP SET FOR OLYMPUS® SCOPES & CO2 WAS INVOLVED IN AN INCIDENT DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD). THE SET WAS USED WITH A CO2 INSUFFLATOR [MODEL ECO 2 PLUS, PART NUMBER (P/N) 2N100-068, SERIAL NUMBER (S/N) (B)(6)], IRRIGATION PUMP (MODEL EIP 2, P/N 103250-000, S/N (B)(6), AND A PORT CONNECTOR (P/N 20325-211). SPECIFICALLY, WHEN INSUFFLATING THE STOMACH WITH CO2, WATER SPRAYED FROM THE DISTAL END OF THE SCOPE AS IF THE PEDAL OF THE IRRIGATION PUMP WAS ACTIVATED. UPON TROUBLESHOOTING THE ISSUE DURING THE CASE, THE CO2 FLOW FROM THE INSUFFLATOR WAS REDUCED FROM HIGH TO MEDIUM WHICH RESOLVED THE SPRAYING/LEAKING PROBLEM. THERE WAS NO REPORT OF ANY PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25071343 ↗MalfunctionMay 4, 2026Leak/Splash
IT WAS REPORTED THAT HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS® SCOPES & CO2 LEAKED AT THE DISTAL END OF SCOPES DURING ENDOSCOPY. ANOTHER LOT OF THE SAME PART NUMBER (LOT NUMBER WO470913, DATE OF MANUFACTURING 10/13/2025, AND EXPIRATION DATE 10/12/2028) WAS ALSO REPORTED TO HAVE LEAKED DURING PROCEDURES. THE SETS WERE USED WITH A CO2 INSUFFLATOR [MODEL ECO 2 PLUS, PART NUMBER 2N100-068) SET ON HIGH CO2 FLOWRATE AS WELL AS AN IRRIGATION PUMP (MODEL EIP 2, PART NUMBER 10325-000). IN ADDITION, THE SETS WERE USED WITH A PORT CONNECTOR (PART NUMBER 20325-211). NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25071321 ↗MalfunctionApr 29, 2026Leak/Splash
IT WAS REPORTED THAT THE HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS® SCOPES & CO2 ARE LEAKING FROM THE DISTAL END OF SCOPES IN NEARLY EVERY UPPER AND LOWER ENDOSCOPY PROCEDURE. THE SETS WERE USED WITH AN ERBE IRRIGATION PUMP, MODEL EIP 2 (PART NUMBER 10325-000) AT 100% FLOWRATE. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25026986 ↗MalfunctionApr 28, 2026Leak/Splash
IT WAS REPORTED THAT THE HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS® SCOPES & CO2 ARE LEAKING AT DISTAL END OF THE SCOPES WHEN CO2 INSUFFLATOR IS ACTIVATED. THE SETS ARE BEING USED WITH AN ERBE IRRIGATION PUMP, MODEL EIP 2 (PART NUMBER 10325-000) AT 100% FLOWRATE. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25014216 ↗MalfunctionApr 28, 2026Leak/Splash
IT WAS REPORTED THAT A HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS® SCOPES LEAKED FROM THE IRRIGATION TUBING AT THE DISTAL END DURING A STANDARD ENDOSCOPY. THE SET WAS USED WITH AN ERBE ENDOSCOPY PORT CONNECTOR FOR OLYMPUS® SCOPES (PART NUMBER: 20325-211, LOT NUMBER WO469953, DATE OF MANUFACTURING 10/20/2025, EXPIRATION DATE 10/01/2028, AND UDI (B)(4). SPECIFICALLY, IT WAS REPORTED THAT THE IRRIGATION FLOW AT THE DISTAL END OF THE SCOPE WAS SIGNIFICANT. THEN, WHEN APPLYING VERY LIGHT PRESSURE TO THE IRRIGATION PUMP'S PUMP HEAD, THE LEAKING CEASED. ANOTHER IRRIGATION PUMP WAS USED WHICH RESOLVED THE LEAKING. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25014173 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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