{ "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": 1 } }, "results": [ { "cfres_id": "220849", "product_res_number": "Z-2776-2026", "event_date_initiated": "2026-06-16", "event_date_posted": "2026-07-22", "recall_status": "Open, Classified", "res_event_number": "99109", "product_code": "HIF", "k_numbers": [ "K243527" ], "product_description": "Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4", "code_info": "Model Number: UHI-4. UDI: 04953170324147, 04953170467219. 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": "Ashley Mitch\n484-5531029", "reason_for_recall": "Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.", "root_cause_description": "Nonconforming Material/Component", "action": "Olympus notified consignees on about 06/16/2026 via letter. Consignees were informed that they many continue to use their UHI-4 until the offset adjustment is performed. However, as noted in the Instructions for Use (IFU), prepare a spare UHI-4 unit as a backup to ensure uninterrupted operation can be completed without complication in the case of a malfunction. Actions to take included to carefully read the notification letter and ensure all personnel are completely knowledgeable on the content of the notification, an Olympus field service representative will contact you to schedule a mutually convenient time to perform the offset adjustment, acknowledge receipt of the notification through the Olympus recall web portal, and forward the notification to other users who may have the affected products if you have further distributed it.", "product_quantity": "3,087 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, El Salvador, Germany, Honduras, Hong Kong, India, Ireland, Japan, Korea, Malaysia, Mexico, Myanmar, New Zealand, Paraguay, Peru, Russia, Singapore, Sri Lanka, Taiwan, Thailand, United Kingdom, Uruguay, Vietnam.", "openfda": { "k_number": [ "K221995", "K201361", "K900878", "K211104", "K150068", "K921264", "K073452", 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