{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "218004", "product_res_number": "Z-1352-2026", "event_date_initiated": "2026-01-16", "event_date_posted": "2026-02-18", "recall_status": "Open, Classified", "res_event_number": "98243", "product_code": "HIF", "k_numbers": [ "K953162" ], "product_description": "Olympus High Flow Insufflation Unit. Model Number: UHI. \n\nUsed for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.", "code_info": "Model Number: UHI; UDI-DI: N/A; All Serial Numbers", "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": "Issue with software algorithm which may lead to overpressure events.", "root_cause_description": "Software design", "action": "Olympus notified consignees on about 01/16/2026 via \"URGENT: MEDICAL DEVICE REMOVAL\" letter. Consignees were instructed to cease usage of the affected product immediately. They are advised to use available alternatives including an existing UHI-4 if available or switching to an insufflation device from another manufacturer. If no alternative is available on site, contact Olympus to arrange a loaner or purchase a replacement.\n\nAdditionally, consignees were instructed to examine inventory and quarantine any identified devices, immediately cease usage of any UHI, UHI-2, and/or UHI-3 in inventory, call Olympus Customer Service at 1-800-848-9024, option 2 to obtain a Return Material Authorization to return your device. Consignees were also requested to acknowledge receipt of this letter through their recall web portal as follows: a. Go to https://olympusamerica.com/recall, b. Enter the recall number \"0489 and c. Complete the form as instructed. Please indicate in your response if you no longer have the device(s).\n\nIf any consignees have further distributed this UHI product, they were instructed to identify affected customers and forward this notice to them immediately.\n\n If you require additional information, please do not hesitate to contact me by phone at (647) 999-3203 or by email at Cynthia.Ow@Olympus.com.", "product_quantity": "18 units", "distribution_pattern": "Nationwide distribution", "openfda": { "k_number": [ "K953162", "K922245", "K930013", "K921756", "K922244", "K260209", "K031014", "K993625", "K102136", "K033991", "K962863", "K242536", "K921963", "K930767", "K041560", "K920114", "K014166", "K991906", "K934115", "K910983", "K934043", "K781913", "K912044", "K173545", "K112357", "K003703", "K812200", "K002328", "K201361", "K132203", "K221995", "K910883", "K905549", "K955073", "K172835", "K981859", "K941685", "K915694", "K922038", "K140263", "K222812", "K944509", "K033614", "K900878", "K070783", "K191780", 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"3016248634", "3002259632", "3010220595", "2020550", "3004084693", "3932", "1450662", "3010041511", "3042953929", "3002807795", "1017294", "3002914049", "3013868968", "3012494290", "1221826", "3030447506", "3010806467", "3015974593", "3008837339", "3013557562", "3009212837", "3001451571", "3003063934", "3002806988", "3008044552", "3033043422" ], "device_name": "Insufflator, Laparoscopic", "medical_specialty_description": "Obstetrics/Gynecology", "regulation_number": "884.1730", "device_class": "2" } } ] }