ERBEFLO CleverCap® 20325-248Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04065655001006), received between Apr 14, 2026 and Jun 18, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionApr 14, 2026Leak/Splash

  IT WAS REPORTED THAT AN INCIDENT OCCURRED WITH A HYBRID CO2 TUBING/CAP SET FOR FUJIFILM SCOPES BEING USED FOR AN UPPER GI PROCEDURE. THE SET WAS USED WITH A 700 SERIES FUJI SCOPE, MV STRATUS CO2 INSUFFLATOR, AND AN ERBE IRRIGATION PUMP MODEL EIP 2 FOR AN UPPER GI PROCEDURE. SPECIFICALLY, LEAKING OCCURRED FROM BOTH SCOPE BUTTONS AS WELL AS OUT THE DISTAL END OF THE SCOPE. UPON CHANGING THE TUBING/CAP SET, THE LEAKING CEASED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24875243 ↗