{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "South Jordan",
      "state": "UT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "94797",
      "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": "U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.",
      "recall_number": "Z-2558-2024",
      "product_description": "Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:    Custom Procedure Kit (Angiography/angioplasty kit), REF:  K12T-10773  K12T-09284D  K12T-10621  K12T-10800  K12T-12491    To support various vascular or cardiac diagnostic and interventional procedures.",
      "product_quantity": "11837 kits",
      "reason_for_recall": "Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.",
      "recall_initiation_date": "20240611",
      "center_classification_date": "20240812",
      "report_date": "20240821",
      "code_info": "Catalog Number/UDI-DI code/Lot Numbers:  K12T-10773    00884450426388 T2800379 T2824129 T2849013 T2857243  K12T-09284D 00884450602102 T2209872 T2220946 T2359067 T2364198 T2508160 T2674429 T2794927 T2800155  K12T-10621 00884450409435 T2308653 T2344516 T2411888 T2428905 T2429939 T2448507 T2452908 T2473123 T2498967 T2531706 T2597113 T2611405 T2629759 T2653268 T2685014 T2691082 T2715028 T2744136 T2776727 T2846077 T2873111  K12T-10800 00884450421093 T2280633 T2407018 T2503204 T2643484 T2680463 T2705035 T2885158  K12T-12491 00884450820605 T2905902",
      "more_code_info": ""
    }
  ]
}