{"recall":{"id":"fda-device-99609","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 4 products","firm":"Olympus Corporation of the Americas","date":"2026-08-19","reported":"2026-09-30","status":"Ongoing","classification":"Class II","products":[{"name":"Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.","code":"Model Number: CD-B610LA. UDI-DI: 00821925039469. Lot Numbers: All unexpired lots.","quantity":"404 units","number":"Z-3244-2026","classification":"Class II"},{"name":"Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.","code":"Model Number: CD-B612LA. UDI-DI: 00821925039476. Lot Number: All unexpired lots.","quantity":"105 units","number":"Z-3245-2026","classification":"Class II"},{"name":"Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.","code":"Lot Code: Model: CD-B620LA. UDI-DI: 00821925039483. Lot Numbers: All unexpired lots.","quantity":"2,142 units","number":"Z-3246-2026","classification":"Class II"},{"name":"Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.","code":"Lot Code: Model: CD-B622LA. UDI-DI: 00821925039452. Lot Numbers: All unexpired lots","quantity":"816 units","number":"Z-3247-2026","classification":"Class II"}],"reason":"Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.","nationwide":true,"states":[],"units":"404 units; 105 units; 2,142 units; 816 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=99609","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"66acbc5a1cec4e4e","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=99609","record":[{"status":"Ongoing","city":"Center Valley","state":"PA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99609","recalling_firm":"Olympus Corporation of the Americas","address_1":"3500 Corporate Pkwy","address_2":"","postal_code":"18034-8229","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.","recall_number":"Z-3244-2026","product_description":"Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. 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Lot Numbers: All unexpired lots.","more_code_info":""},{"status":"Ongoing","city":"Center Valley","state":"PA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99609","recalling_firm":"Olympus Corporation of the Americas","address_1":"3500 Corporate Pkwy","address_2":"","postal_code":"18034-8229","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.","recall_number":"Z-3245-2026","product_description":"Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. 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Lot Number: All unexpired lots.","more_code_info":""},{"status":"Ongoing","city":"Center Valley","state":"PA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99609","recalling_firm":"Olympus Corporation of the Americas","address_1":"3500 Corporate Pkwy","address_2":"","postal_code":"18034-8229","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.","recall_number":"Z-3246-2026","product_description":"Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. 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Lot Numbers: All unexpired lots.","more_code_info":""},{"status":"Ongoing","city":"Center Valley","state":"PA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99609","recalling_firm":"Olympus Corporation of the Americas","address_1":"3500 Corporate Pkwy","address_2":"","postal_code":"18034-8229","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.","recall_number":"Z-3247-2026","product_description":"Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.","product_quantity":"816 units","reason_for_recall":"Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.","recall_initiation_date":"20260819","center_classification_date":"20260918","report_date":"20260930","code_info":"Lot Code: Model: CD-B622LA. UDI-DI: 00821925039452. Lot Numbers: All unexpired lots","more_code_info":""}]}}