ERBEFLO CleverCap® 20325-206Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04065655000436), received between Apr 20, 2026 and May 19, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 reports).

1 FDA recall record name this device's 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, 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.

Recalls naming this device

1. Mar 31, 2026Open, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• 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 ↗
• MalfunctionApr 21, 2026Leak/Splash

  IT WAS REPORTED THAT THE HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS® SCOPES UNCONTROLLABLY LEAKED. SPECIFICALLY, WHEN THE IRRIGATION TUBING OF A SET IS CONNECTED TO A BIPOLAR GOLD PROBE, IT LEAKS FROM THE PROBE. ANOTHER LOT OF THE SAME PART NUMBER [LOT NUMBER (L/N) WO471077, DATE OF MANUFACTURING (DOM) 10/14/25, AND EXPIRATION DATE (EXP. DATE) 10/13/28 WAS ALSO A PART OF THE COMPLAINT. THE SETS WERE ALSO BEING USED WITH A CO2 OLYMPUS® CONNECTOR TUBES (PART NUMBER 20325-219, UDI: (B)(4), L/N WO458250, DOM 05/13/25, AND EXP. DATE 05/12/28; L/N WO465958, DOM 08/13/25, AND EXP. DATE 08/12/28; AS WELL AS L/N WO465959, DOM 08/13/25, AND EXP. DATE 08/12/28). NO INJURY TO ANY PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24941771 ↗
• MalfunctionApr 20, 2026Leak/Splash

  IT WAS REPORTED THAT MULTIPLE LOTS OF HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS® SCOPES LEAKED FROM THE IRRIGATION TUBING AT THE DISTAL END WITH EVERY SET DURING STANDARD ENDOSCOPY (NOTE: THE OTHER SPECIFIC INVOLVED LOTS WERE NOT KNOWN.). NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24932646 ↗