{"recall":{"id":"fda-device-99326","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Micro Therapeutics, Inc. recalls 2 products","firm":"Micro Therapeutics, Inc.","date":"2026-06-08","reported":"2026-07-29","status":"Ongoing","classification":"Class II","products":[{"name":"Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12. Intracranial aneurysm flow diverter","code":"UDI: 00763000448806/ Lot: D062612","quantity":"11 units","number":"Z-2773-2026","classification":"Class II"},{"name":"Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm flow diverter","code":"UDI: 00763000448844/ Lot: D062531","quantity":"6 units","number":"Z-2774-2026","classification":"Class II"}],"reason":"Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, \tWA.","nationwide":true,"states":[],"units":"11 units; 6 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=99326","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"bf765b8cbc3b78ee","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=99326","record":[{"status":"Ongoing","city":"Irvine","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99326","recalling_firm":"Micro Therapeutics,  Inc.","address_1":"9775 Toledo Way","address_2":"N/A","postal_code":"92618-1811","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Visit","distribution_pattern":"US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, \tWA.","recall_number":"Z-2773-2026","product_description":"Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12. Intracranial aneurysm flow diverter","product_quantity":"11 units","reason_for_recall":"Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.","recall_initiation_date":"20260608","center_classification_date":"20260722","report_date":"20260729","code_info":"UDI: 00763000448806/ Lot: D062612"},{"status":"Ongoing","city":"Irvine","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99326","recalling_firm":"Micro Therapeutics,  Inc.","address_1":"9775 Toledo Way","address_2":"N/A","postal_code":"92618-1811","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Visit","distribution_pattern":"US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, \tWA.","recall_number":"Z-2774-2026","product_description":"Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm flow diverter","product_quantity":"6 units","reason_for_recall":"Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.","recall_initiation_date":"20260608","center_classification_date":"20260722","report_date":"20260729","code_info":"UDI: 00763000448844/ Lot: D062531"}]}}