{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "210042", "product_res_number": "Z-0066-2025", "event_date_initiated": "2024-08-19", "event_date_posted": "2024-10-11", "recall_status": "Open, Classified", "res_event_number": "95343", "product_code": "DXT", "k_numbers": [ "K160107" ], "product_description": "DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A", "code_info": "REF/UDI-DI/Lot(Expiration):\nIN9135/A/00884450409640/H2918441(4/15/2027).\n\nIN9152/A/00884450409657/H2912682(4/8/2027)", "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": "Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.", "root_cause_description": "Packaging process control", "action": "On 8/19/24, recall notices were emailed to customers asking them to do the following:\n\n1) If affected devices are discovered, quarantine them, discontinue use and distribution, and return to the recalling firm.\n2) Ensure that applicable personnel within your organization are made aware of this field action.\n3) If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the customer response form.\n4) Complete and return the customer response form via email to response@merit.com \n\nIf you have any questions concerning this communication, please contact the firm's Sales\nRepresentatives or Customer Service via email at RESPONSE@merit.com or via phone at +1 800 356 3748, Hours: 6 am to 6 pm MST, Mon-Fri.", "product_quantity": "290", "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.", "openfda": { "k_number": [ "K182273", "K863537", "K911166", "K905819", "K033247", "K863596", "K934086", "K023183", "K182289", "K113133", "K020892", "K062168", "K000013", "K203004", "K140469", "K904212", "K061976", "K072886", "K170431", "K163084", "K844045", "K171698", "K873597", "K924116", "K140425", "K890292", "K910873", "K984088", "K875324", "K912944", "K142081", "K833138", "K142745", "K232388", "K012950", "K873410", "K911549", "K964642", "K823253", "K973230", "K051799", "K090621", 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"3034544377", "3020298301", "1000123180", "1000208624", "1000112968", "3012395857", "2521402", "3002808086", "3011334555", "3007361214", "3015225571", "3002963732", "3009746061", "3009051888", "1526711", "3007048453" ], "device_name": "Injector And Syringe, Angiographic", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1650", "device_class": "2" } } ] }