{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 30 } }, "results": [ { "cfres_id": "218019", "product_res_number": "Z-1268-2026", "event_date_initiated": "2026-01-07", "event_date_posted": "2026-02-05", "recall_status": "Open, Classified", "res_event_number": "98252", "product_code": "KNS", "k_numbers": [ "K250945" ], "product_description": "Brand Name: CleverCut\nProduct Name: Single Use 3-Lumen Sphincterotome V\nModel/Catalog Number: KD-V411M-0320;\nSoftware Version: N/A\nProduct Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.", "code_info": "Model/Catalog Number: KD-V411M-0320;\nMaterial REF: (1) N1089430, (2) N1089410, (3) N5411130;\nUDI-DI: (1) 04953170183973, (2) 04953170466274, (3) 04953170380556;\n\nAll Lots with a valid expiration date", "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": "Devices which did not undergo thermoforming could deform and lose performance.", "root_cause_description": "Process control", "action": "On or around January 7, 2026, URGENT: MEDICAL DEVICE REMOVAL letters were sent to customers. Actions to be taken: \nthe following actions:\n1. Examine your inventory and quarantine any identified devices immediately.\n2. Immediately cease usage of any affected product in your inventory.\n3. Please contact Customer Service at 1-800-848-9024, option 2, to obtain a Return Material Authorization. Olympus will arrange for the return of your device to Olympus. Olympus will issue a credit to your facility upon receipt of your affected product.\n4. Olympus requests that you acknowledge receipt of this letter through our recall web portal:\na. Go to https://olympusamerica.com/recall\nb. Enter the recall number: \"0487 \nc. Complete the form as instructed.\n5. If you have further distributed it, please forward this notice to other users who may have the affected products.\nOlympus requests you to report any complaints to our Technical Assistance Center (TAC) at 1-800-848-9024, option 1, and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.\nOlympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me at Cynthia.Ow@olympus.com or by phone at (647) 999-3203.", "product_quantity": "72023 units (3920 US, 68103 OUS)", "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.", "openfda": { "k_number": [ "K002236", "K800975", "K884306", "K173559", "K896426", "K970945", "K960231", "K920089", "K845015", "K861904", "K002802", "K200404", "K002583", "K911648", "K232825", "K896612", "K990376", "K150142", "K961349", "K992402", "K913881", "K150786", "K250351", "K223256", "K251104", "K982557", "K973366", "K011787", "K895855", "K242061", "K810336", "K860366", "K133933", "K182408", "K851964", "K991847", "K082464", "K851652", "K212999", "K800915", "K141991", "K911600", "K092309", "K251226", 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