ERBE 20325-239Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04050147020535), received between Jun 16, 2023 and Jan 24, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Prime” (1 report).

1 other recall cover devices cleared under the same FDA submission (K162152); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2024

  ERBEFLO CLEVERCAP TUBING WAS BROKE WHEN WE OPENED THE PACKAGE. ONE OF THE TUBES IS BROKE/SLICED NEAR THE BLUE CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18571012 ↗
• MalfunctionJun 16, 2023Failure to Prime

  ENDOSCOPY PROCEDURE: WHEN PRIMING THE ERBEFLO CLEVERCAP TUBING WITH WATER, FOR THE ENDOSCOPY TOWER SET UP WITH CO2, TUBING WOULD NOT PRIME. NO WATER INTO TUBING. TROUBLESHOT TUBING FOR 10 MINUTES WITHOUT SUCCESS AND CHANGED TUBING AND SUCCESSFULLY PRIMED. NO HARM TO PATIENT, DELAY IN START OF PROCEDURE. MANUFACTURER RESPONSE FOR PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE, ERBE (PER SITE REPORTER) WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17142928 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162152. One submission often covers many models, so check the product and lot details in each record.

• Z-2062-2026 · Mar 31, 2026 · Open, Classified
  ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap Set for Olympus Scopes & UCR, REF: 20325-240; Hybrid CO2 Tu