ERBEFLO CleverCap® 20325-208Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04065655001099), received between Apr 7, 2026 and Apr 7, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Leak/Splash

  IT WAS REPORTED THAT THE HYBRID CO2 TUBING/CAP SETS FOR FUJINON SCOPES LEAKED FROM THE IRRIGATION LINE. ALSO, CAPS ARE SKIPPING THREADS AND POPPING OFF WHEN THREADED ON TO BAXTER BOTTLES IF NOT DONE PERFECTLY. ANOTHER SIMILAR PRODUCT {HYBRID CO2 TUBING/CAP SETS FOR FUJIFILM SCOPES, PART NUMBER 20325-248, LOT NUMBERS W4467056 [DATE OF MANUFACTURING (DOM) 08/28/25, EXPIRATION DATE 08/27/2028] AND WO471252 (DOM 10/16/25, EXPIRATION DATE 10/15/2028), UDI: (B)(4)} WAS A PART OF THE COMPLAINT. THE SETS WERE USED WITH AN ERBE IRRIGATION PUMP MODEL EIP2 AND ERBE CO2 INSUFFLATOR MODEL ECO2. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24799984 ↗