Erbe Medical, LLC — ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 31, 2026
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.
What's affected?
- Product
- ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
- Brand
- Erbe Medical, LLC
- Lot code
- W4465580
Additional details
UDI-DI: 04065655000252. Lots: W4465580, W4466022, W4466023, WO469442, WO469923, WO473978, WO473979, WO473980, WO473981, WO476347, WO477013, WO477014
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 5,500.
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