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Erbe Medical, LLC recalls ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
Recalled May 13, 2026 · FDA recall Z-2064-2026 · Erbe Medical
Hazard
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. · FDA Class II
Units
5,500
Sold at
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.
Description
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.
Product
ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
Manufacturer(s)
Erbe Medical, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →