ERBEFLO CleverCap® 20325-240Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04065655000405), received between Apr 16, 2026 and May 14, 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.

• 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 ↗
• MalfunctionApr 17, 2026Leak/Splash

  IT WAS REPORTED THAT THE HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS® SCOPES & UCR LEAKED FROM THE DISTAL END OF THE SCOPES WHEN USED WITH A BOSTON SCIENTIFIC CONNECTORS. ADDITIONALLY, THE CAPS ARE SKIPPING THREADS AND POPPING OFF WHEN THREADED ON TO A BAXTER BOTTLE IF NOT DONE PERFECTLY. IN ONE CASE, DURING AN UPPER ENDOSCOPY, A PATIENT ASPIRATED DUE TO EXCESS WATER LEAKING FROM THE DISTAL END OF THE OLYMPUS SCOPE. NO INJURIES OCCURRED. OTHER LOT NUMBERS OF THE SAME PART NUMBER [LOT NUMBER (L/N) WO469446, DATE OF MANUFACTURING (DOM) 09/25/25, AND EXPIRATION DATE (EXP. DATE) 09/24/28; L/N WO471246, DOM 10/15/25, AND EXP. DATE 10/14/28; L/N WO473983, DOM 11/12/25, AND EXP. DATE 11/11/28; AS WELL AS L/N WO473984, DOM 11/12/25, AND EXP. DATE 11/11/28] WERE ALSO A PART OF THE COMPLAINT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24916643 ↗
• MalfunctionApr 16, 2026Leak/Splash

  IT WAS REPORTED THAT THE HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS® SCOPES & UCR LEAKED WATER AT THE DISTAL AT THE END OF THE SCOPE. ANOTHER LOT NUMBER OF THE SAME PART NUMBER (LOT NUMBER WO473174, DATE OF MANUFACTURING 11/24/25, AND EXPIRATION DATE 11/05/28) WAS ALSO A PART OF THE COMPLAINT. THE SETS WERE USED WITH AN OLYMPUS 190 SERIES SCOPES, OLYMPUS CO2 INSUFFLATOR MODEL UCR, AND BOSTON SCIENTIFIC PORT CONNECTORS. THERE WERE NO REPORTS OF ANY PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24900087 ↗