{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "210293", "product_res_number": "Z-0229-2025", "event_date_initiated": "2024-08-23", "event_date_posted": "2024-10-25", "recall_status": "Open, Classified", "res_event_number": "95440", "product_code": "FEQ", "k_numbers": [ "K100899" ], "product_description": "Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)", "code_info": "UDI-DI: 15019778003191;\nSerial Numbers: 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"firm_fei_number": "2429304", "recalling_firm": "Olympus Corporation of the Americas", "address_1": "3500 Corporate Pkwy", "city": "Center Valley", "state": "PA", "postal_code": "18034-8229", "additional_info_contact": "Cynthia Ow\n647-9993203", "reason_for_recall": "During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure.", "root_cause_description": "Equipment maintenance", "action": "An URGENT: MEDICAL DEVICE CORRECTION notification letter dated 9/20/24 was sent to customers.\n\nActions Required:\nOur records indicate that your facility has purchased one or more of the affected products. The range of affected serial numbers is included at the top of this letter. The serial number is on a label affixed to the back of the OFP-2 pump.\n\nAn Olympus representative will create a Return Material Authorization for the return of your device to Olympus for an inspection. You may continue to use your OFP-2 pump until an Olympus representative performs the inspection. If the OFP-2 fails the inspection, the OFP-2 will require repair.\n\nAdditionally, Olympus requires you to take the following actions:\n1. Carefully read the content of this notification.\n2. Olympus requests that you acknowledge receipt of this letter. Access the Olympus recall portal to indicate that you have received this notification.\na. Go to https://olympusamerica.com/recall\nb. Enter the recall number \"0455 \nc. Complete the form as instructed.\n3. If you have further distributed this product, identify your customers, and forward them this notification.\n4. Beginning November 2024, please contact Olympus Customer Service at 1-800-848-9024, option 3, to request an Air Switch Assembly Inspection . Olympus will arrange for the return of your device to our Olympus Repair Center at a mutually convenient time. The Olympus representative s record of repair will also serve as the completion record of this action for your facility.\n\nOlympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail at Cynthia.Ow@Olympus.com.", "product_quantity": "445 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K101146", "K120123", "K120862", "K161482", "K100803", "K163424", "K112576", "K100899", "K132340", "K220395", "K153588", "K133747", "K182258", "K191559", "K092429", "K173650", "K000948", "K162152", "K153362", "K142155", "K103696" ], "registration_number": [ "3002808022", "3013348547", "2183446", "9610617", "1000121056", "3005099803", "3002807315", "3008264255", "1643817", "3007389669", "1528319", "3007007790", "3004111573", "2246552", "1651395", "3013247477", "1047843", "3003724334", "3042872931", "3008132398", "3014926389", "1721676", "2518897", "3006946348", "3014342096", "3017907746", "1649518", "3009106214", "3010202439", "9611174", "3032507796", "9610773", "1722746", "3004167615", "9681260", "3004530184", "3005726841", "3010155648", "3017262662", "1650907", "2528981", "3002807310", "2020550", "3008573567", "3020712480", "3015219237" ], "fei_number": [ "3003012447", "3002808022", "3013348547", "2183446", "1000121056", "3005099803", "3001236277", "3002808268", "3002807315", "3008264255", "1643817", "3007389669", "3007475226", "3007007790", "3004111573", "2246552", "3013247477", "1047843", "3003724334", "3042872931", "1000122656", "3014926389", "3002806565", "1721676", "3006946348", "3014342096", "3002807091", "1000306216", "3017907746", "3009106214", "3032507796", "3002807798", "3004167615", "3004530184", "1000080301", "3002681132", "3005726841", "3010155648", "3017262662", "1000162602", "2528981", "3002807310", "2020550", "3008573567", "3020712480", "3015219237" ], "device_name": "Pump, Air, Non-Manual, For Endoscope", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }