Class II — Erbe Medical, LLC
| Recalling firm | Erbe Medical, LLC |
|---|---|
| Registered facility | ERBE MEDICAL, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222 |
| Quantity | 5,500 |
| 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. |
| Initiated | 2026-03-31 |
| Classified | 2026-05-01 |
| Recall number | Z-2064-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Erbe Medical, LLC (Z-2064-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98674/
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