- Recalling firm
- Erbe Medical, LLC
- Reason for recall
- 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.
- Affected products (lot / model / serial)
- UDI-DI: 04065655000252. Lots: W4465580, W4466022, W4466023, WO469442, WO469923, WO473978, WO473979, WO473980, WO473981, WO476347, WO477013, WO477014
- Units affected
- 5,500
- Distribution pattern
- 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.
- Firm location
- Tempe, AZ, United States
- Recall type
- Voluntary: Firm initiated
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2064-2026
- Recall initiated
- March 31, 2026
- FDA classification date
- May 1, 2026
- FDA report date
- May 13, 2026
- FDA event ID
- 98674
- Last updated on HTM Vibe
- July 24, 2026