{"url_path":"/fda/device/recalls/Z-2063-2026","section_key":"summary","section_title":"DEVICE Recall: Erbe Medical, LLC — ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-03-31","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2063-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Erbe Medical, LLC"},"word_count":182,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2063-2026\n\n**Recalling firm:** Erbe Medical, LLC\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-03-31\n**Report date:** 2026-05-13\n\n## Product\nERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;\n\n## Reason\nDevices 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.\n\n## Affected lots\nREF/UDI-DI/Lots:  20325-201/04065655000603/W4466253, W4466254, W4466256, W4466257, W4466258, WO471080, WO471081, WO471083, WO471084, WO473975, WO473976, WO477586, WO477587, WO477588, WO477589, WO477590;  20325-203/04065655001211/WO473986\n\n## Distribution\nUS 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."}