{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-28", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "221797", "product_res_number": "Z-3305-2026", "event_date_initiated": "2026-08-10", "event_date_posted": "2026-09-25", "recall_status": "Open, Classified", "res_event_number": "99541", "product_code": "KRD", "k_numbers": [ "K181300" ], "product_description": "Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: \r\nS420GH/EUA, S620GH/EUA;\r\n\r\nEmbosphere 700-900 micrometer 2 mL Syringe Sterile Steam, REF: S820GH/CAB;\r\n\r\nEmbosphere 900-1200 micrometer 2 mL Syringe Sterile Steam, REF: S1020GH/C, S1020GH/EUA", "code_info": "S420GH/EUA/00884450116715/X3467294-1,\nS620GH/EUA/00884450109519/X3472987-1,\nS820GH/CAB/00884450364154/X3472923-A,\nS1020GH/C/00884450403136/X3482321-5,\nS1020GH/EUA/00884450109519/X3482321-1.", "firm_fei_number": "1721504", "recalling_firm": "Merit Medical Systems, Inc.", "address_1": "1600 W Merit Pkwy", "city": "South Jordan", "state": "UT", "postal_code": "84095-2416", "additional_info_contact": "801-253-1600", "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.", "root_cause_description": "Process control", "action": "On 8/10/2026, recall notices were mailed and emailed to customers who were asked to do the following:\n\n1) Discontinue use and return affected devices to firm.\n2) Ensure that applicable personnel within your organization are made aware of this recall.\n3) If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them. \n4) Complete and return the response form via email to RESPONSE@merit.com \n\nIf you have any questions concerning this communication, please contact the firm's Customer Service via email at RESPONSE@merit.com or via phone at +1 800 356 3748.\n\nCanadian customers can contact the firm at at Canada@merit.com or by phone at\n+1 800 364 4370.", "product_quantity": "104", "distribution_pattern": "Worldwide - 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