Erbe Medical, LLC recalls ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes

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.

On 3/31/2026, correction notices were emailed to Medical Directors, Risk Managers, Medical Device Safety Officers, or Healthcare Professionals informing them to take the following actions: 1) Discontinue use of unsupported third-party Scope Port Connectors. 2) Provide this notice to all personnel within your organization who use, service, purchase, stock, or otherwise manage. 3) If you further distributed any affected devices, promptly forward this notice to those accounts and request that they take the same actions. 4) Continue following the instructions for use, including verifying connector compatibility, ensuring that all connectors are fully seated, confirming that all joints and interfaces are secure, and verifying correct placement and alignment of the tubing within the pump head. 5) Utilize the compatibility table in the notice until updated Notes on Use is received. 6) Complete and return the response form via email to fieldaction.medical.us@erbegroup.com. Firm contacts: Correction: fieldaction.medical.us@erbegroup.com, 480-564-1899. Routine Customer Service and Complaints: techservices@erbegroup.com, 1-800-778-3723

• FDA enforcement recordOfficial FDA database entry for Z-2063-2026
• FDA 510(k) clearance · K221177The device's official FDA premarket clearance record
• FDA device classification · OCXOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.1500The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Erbe Medical, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.