{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "219412", "product_res_number": "Z-2062-2026", "event_date_initiated": "2026-03-31", "event_date_posted": "2026-05-01", "recall_status": "Open, Classified", "res_event_number": "98674", "product_code": "FEQ", "k_numbers": [ "K132340", "K162152" ], "product_description": "ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap Set for Olympus Scopes & UCR, REF: 20325-240; Hybrid CO2 Tubing/Cap Set for Olympus Scopes, REF: 20325-206; Hybrid CO2 Tubing/Cap Set for Pentax Scopes, REF: 20325-207; ERBEFLO CleverCap Hybrid CO2 Tubing/Cap Set for Fujifilm Scopes, REF: 20325-248; Hybrid CO2 Tubing/Cap Set for Fujinon Scopes, REF: 20325-208", "code_info": "REF/UDI-DI/Lots: \n20325-239/04065655000375/W4464506, W4464507, W4464512, W4464514, W4464515, W4464516, W4464517, W4465114, W4465115, W4465116, W4465702, W4465709, W4465991, W4466004, W4466266, W4466267, W4466268, W4466269, W4466271, W4466272, W4466273, W4466275, W4466278, W4466279, W4466813, W4466814, W4466815, W4466816, W4467057, W4467058, W4467059, W4467680, W4467681, W4468147, W4468148, W4468273, W4468274, W4468275, WO468776, WO468777, WO468778, WO468779, WO468780, WO469443, WO469444, WO469448, WO469449, WO469450, WO469451, WO469452, WO469933, WO469934, WO469947, WO469948, WO469949, WO469950, WO469951, WO469952, WO470768, WO470774, WO470775, WO470776, WO470777, WO470778, WO470896, WO470897, WO470913, WO470914, WO470915, WO470922, WO471236, WO471237, WO471238, WO471239, WO471240, WO471241, WO471242, WO473987, WO473988, WO473989, WO473991, WO475246, WO475247, WO475248, WO475249;\n\n20325-240/04065655000405/W4466020, W4466021, WO468768, WO468769, WO468770, WO468771, WO469445, WO469446, WO469447, WO469936, WO469937, WO471244, WO471246, WO473170, WO473171, WO473172, WO473173, WO473174, WO473982, WO473983, WO473984, WO473985, WO474409, WO474410, WO474411, WO474412, WO474413, WO474414, WO475243;\n\n20325-206/04065655000436/W4467039, W4467049, W4467678, W4467679, WO468582, WO470769, WO470770, WO470771, WO470772, WO470773, WO471076, WO471077, WO471078, WO471079, WO471390, WO478365, WO478366, WO478367;\n\n20325-207/04065655000689/W4469939, W4469940, W4469941;\n\n20325-248/04065655001006/W4467050, W4467051, W4467055, W4467056, W4467682, WO470898, WO470899, WO470900, WO470901, WO470902, WO470903, WO471252, WO471253, WO471254, WO471255, WO471256;\n\n20325-208/04065655001099/W4467040, W4468271, WO468760", "firm_fei_number": "3020712480", "recalling_firm": "Erbe Medical, LLC", "address_1": "405 W Geneva Dr", "city": "Tempe", "state": "AZ", "postal_code": "85282-2003", "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.", "root_cause_description": "Component change control", "action": "On 3/31/2026, correction notices were emailed to Medical Directors, Risk Managers, Medical Device Safety Officers, or Healthcare Professionals informing them to take the following actions:\n1) Discontinue use of unsupported third-party Scope Port Connectors.\n2) Provide this notice to all personnel within your organization who use, service, purchase, stock, or otherwise manage. \n3) If you further distributed any affected devices, promptly forward this notice to those\naccounts and request that they take the same actions.\n4) Continue following the instructions for use, including verifying connector compatibility, ensuring that all connectors are fully seated, confirming that all joints and interfaces are secure, and verifying correct placement and alignment of the tubing within the pump head.\n5) Utilize the compatibility table in the notice until updated Notes on Use is received.\n6) Complete and return the response form via email to fieldaction.medical.us@erbegroup.com.\n\nFirm contacts: Correction: fieldaction.medical.us@erbegroup.com, 480-564-1899. Routine Customer Service and Complaints: techservices@erbegroup.com, 1-800-778-3723", "product_quantity": "260,962", "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.", "openfda": { "k_number": [ "K000948", "K133747", "K112576", "K161482", "K191559", "K132340", "K162152", "K100899", "K173650", "K101146", "K153588", "K120862", "K092429", "K220395", "K100803", "K120123", "K153362", "K163424", "K182258", "K103696", "K142155" ], "registration_number": [ "3002808022", "1047843", "1643817", "3006946348", "3005726841", "3002807315", "9611174", "2246552", "1722746", "9610773", "3002807310", "3014926389", "3004167615", "1650907", "2518897", "9610617", "2020550", "3032507796", "3009106214", "3010155648", "3004111573", "9681260", "3004530184", "3042872931", "2183446", "1649518", "3008264255", "3014342096", "3008573567", "3013247477", "1721676", "3007007790", "1651395", "3003724334", "3015219237", "3005099803", "1000121056", "3017907746", "2528981", "1528319", "3007389669", "3013348547", "3008132398", "3017262662", "3020712480", "3010202439" ], "fei_number": [ "1000122656", "3002808022", "1047843", "1000306216", "1643817", "3006946348", "3005726841", "3003012447", "3002807315", "2246552", "3002807310", "3014926389", "3004167615", "3002807091", "3032507796", "3009106214", "2020550", "3004111573", "3010155648", "3004530184", "3042872931", "2183446", "3002681132", "1000162602", "3008264255", "3014342096", "3008573567", "3013247477", "3007475226", "1721676", "3007007790", "3003724334", "3015219237", "3002806565", "3001236277", "1000121056", "3005099803", "3017907746", "2528981", "3007389669", "3013348547", "3002808268", "3017262662", "1000080301", "3002807798", "3020712480" ], "device_name": "Pump, Air, Non-Manual, For Endoscope", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }