Erbe Medical, Llc: Endoscopic Irrigation/suction System

Recall Summary Erbe Medical is recalling ERBEFLO CleverCap tubing and cap sets used with Olympus and Fujifilm endoscopes because the connector design may allow unintended water to flow from the device tip during use with certain third-party connectors. This unintended water flow could be inhaled by patients during procedures, potentially leading to serious respiratory complications including aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure. The affected devices were distributed nationwide across all U.S. states and territories.

Recalling firm: Erbe Medical, LLC
Product: ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;
Reason: 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.
Classification: Class II
Category: medical device recall
Country: United States
Agency: FDA-DEVICES
Recall date: 2026-03-31
Status: Open, Classified
Areas affected: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution: US Nationwide distribution including in the states of IL, NY, CA, WA, UT, KY, PA, TX, AL, OH, FL, IN, NJ, NH, MI, CT, AR, MN, WI, AZ, CO, WV, MT, HI, TN, GA, VA, OK, RI, MO, NM, ID, SC, WY, KS, NC, MS, OR, MD, MA, DE, NE, AK, IA, DC, ME, LA, SD, ND, VT, PR, NV.

Recall details on Nibble Recalls: https://trynibble.app/recalls/d4fe4c85-464e-4701-abf0-57853254da90