Erbe Medical, Llc: Pump, Air, Non-manual, For Endoscope
Recall Summary Erbe Medical is recalling ERBEFLO CleverCap CO2 tubing and cap sets used with endoscopes because the connector design may allow unintended water leakage from the scope tip when used with certain third-party connectors. This water leakage could be inhaled into the lungs, potentially causing serious respiratory complications including pneumonia, acute respiratory distress syndrome, or respiratory failure. The affected devices were distributed nationwide to hospitals and medical facilities across all U.S. states and Puerto Rico.
- Recalling firm
- Erbe Medical, LLC
- Product
- 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 Tubing/Cap Set for Olympus Scopes, REF: 20325-206; Hybrid CO2 Tubing/Cap Set for Pentax Scopes, REF: 20325-207; ERBEFLO CleverCap Hybrid CO2 Tubing/Cap Set for Fujifilm Scopes, REF: 20325-248; Hybrid CO2 Tubing/Cap Set for Fujinon Scopes, REF: 20325-208
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/8eca7c68-b318-4efe-8e7a-c3ee7d65470b