{"recall":{"id":"fda-device-99109","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Olympus Corporation of the Americas recalls Olympus High Flow Insufflation Unit - UHI-4","firm":"Olympus Corporation of the Americas","date":"2026-06-16","reported":"2026-07-29","status":"Ongoing","classification":"Class II","products":[{"name":"Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4","code":"Model Number: UHI-4. UDI: 04953170324147, 04953170467219. All Serial Numbers.","quantity":"3,087 units","number":"Z-2776-2026","classification":"Class II"}],"reason":"Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"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.","nationwide":true,"states":[],"units":"3,087 units","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99109","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"35d1ca1b91ab9e48","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99109","record":[{"status":"Ongoing","city":"Center Valley","state":"PA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99109","recalling_firm":"Olympus Corporation of the Americas","address_1":"3500 Corporate Pkwy","address_2":"N/A","postal_code":"18034-8229","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","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.","recall_number":"Z-2776-2026","product_description":"Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4","product_quantity":"3,087 units","reason_for_recall":"Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.","recall_initiation_date":"20260616","center_classification_date":"20260722","report_date":"20260729","code_info":"Model Number: UHI-4. UDI: 04953170324147, 04953170467219. All Serial Numbers."}]}}