{"recall":{"id":"fda-device-98869","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":"2026-05-05","reported":"2026-07-22","status":"Ongoing","classification":"Class II","products":[{"name":"Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.","code":"Model Number: 188. UDI-DI: 00821925001053. All Lot Numbers.","quantity":"190 units","number":"Z-2718-2026","classification":"Class II"},{"name":"Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.","code":"Model Number: 188A. UDI-DI: 00821925001077. All Lot Numbers","quantity":"1,156 units","number":"Z-2719-2026","classification":"Class II"},{"name":"Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.","code":"Model Number: 194. UDI-DI: 0082192500586. All Lot Numbers.","quantity":"3,241 units","number":"Z-2720-2026","classification":"Class II"},{"name":"Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.","code":"Model Number: 190A. UDI-DI: 00821925003538. All Lot Numbers.","quantity":"3,663 units","number":"Z-2721-2026","classification":"Class II"}],"reason":"Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.","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, Japan, EU, and Latin America.","nationwide":true,"states":[],"units":"190 units; 1,156 units; 3,241 units; 3,663 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=98869","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"51a147510c6765bc","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=98869","record":[{"status":"Ongoing","city":"Center Valley","state":"PA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"98869","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, Japan, EU, and Latin America.","recall_number":"Z-2718-2026","product_description":"Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.","product_quantity":"190 units","reason_for_recall":"Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.","recall_initiation_date":"20260505","center_classification_date":"20260710","report_date":"20260722","code_info":"Model Number: 188. UDI-DI: 00821925001053. All Lot Numbers.","more_code_info":""},{"status":"Ongoing","city":"Center Valley","state":"PA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"98869","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, Japan, EU, and Latin America.","recall_number":"Z-2719-2026","product_description":"Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.","product_quantity":"1,156 units","reason_for_recall":"Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.","recall_initiation_date":"20260505","center_classification_date":"20260710","report_date":"20260722","code_info":"Model Number: 188A. UDI-DI: 00821925001077. All Lot Numbers","more_code_info":""},{"status":"Ongoing","city":"Center Valley","state":"PA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"98869","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, Japan, EU, and Latin America.","recall_number":"Z-2720-2026","product_description":"Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.","product_quantity":"3,241 units","reason_for_recall":"Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.","recall_initiation_date":"20260505","center_classification_date":"20260710","report_date":"20260722","code_info":"Model Number: 194. UDI-DI: 0082192500586. All Lot Numbers.","more_code_info":""},{"status":"Ongoing","city":"Center Valley","state":"PA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"98869","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, Japan, EU, and Latin America.","recall_number":"Z-2721-2026","product_description":"Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.","product_quantity":"3,663 units","reason_for_recall":"Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.","recall_initiation_date":"20260505","center_classification_date":"20260710","report_date":"20260722","code_info":"Model Number: 190A. UDI-DI: 00821925003538. All Lot Numbers.","more_code_info":""}]}}