{"recall":{"id":"fda-device-99541","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Merit Medical Systems, Inc. recalls Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam","firm":"Merit Medical Systems, Inc.","date":"2026-08-10","reported":"2026-10-07","status":"Ongoing","classification":"Class II","products":[{"name":"Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2 mL Syringe Sterile Steam, REF: S820GH/CAB; Embosphere 900-1200 micrometer 2 mL Syringe Sterile Steam, REF: S1020GH/C, S1020GH/EUA","code":"S420GH/EUA/00884450116715/X3467294-1, S620GH/EUA/00884450109519/X3472987-1, S820GH/CAB/00884450364154/X3472923-A, S1020GH/C/00884450403136/X3482321-5, S1020GH/EUA/00884450109519/X3482321-1,","quantity":"104","number":"Z-3305-2026","classification":"Class II"}],"reason":"Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, which if used could lead to infection.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - US Nationwide distribution in the states of CA, GA and the countries of  France, Ireland, Canada, Switzerland.","nationwide":true,"states":[],"units":"104","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=99541","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"f70a750de42c95e9","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=99541","record":[{"status":"Ongoing","city":"South Jordan","state":"UT","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99541","recalling_firm":"Merit Medical Systems, Inc.","address_1":"1600 W Merit Pkwy","address_2":"","postal_code":"84095-2416","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution in the states of CA, GA and the countries of  France, Ireland, Canada, Switzerland.","recall_number":"Z-3305-2026","product_description":"Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF:   S420GH/EUA, S620GH/EUA;    Embosphere 700-900 micrometer 2 mL Syringe Sterile Steam, REF: S820GH/CAB;    Embosphere 900-1200 micrometer 2 mL Syringe Sterile Steam, REF: S1020GH/C, S1020GH/EUA","product_quantity":"104","reason_for_recall":"Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, which if used could lead to infection.","recall_initiation_date":"20260810","center_classification_date":"20260925","report_date":"20261007","code_info":"S420GH/EUA/00884450116715/X3467294-1, S620GH/EUA/00884450109519/X3472987-1, S820GH/CAB/00884450364154/X3472923-A, S1020GH/C/00884450403136/X3482321-5, S1020GH/EUA/00884450109519/X3482321-1,","more_code_info":""}]}}