{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Winter Springs",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91846",
      "recalling_firm": "Iradimed Corporation",
      "address_1": "1025 Willa Springs Dr",
      "address_2": "N/A",
      "postal_code": "32708-5235",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Austria, Canada, Chile, Denmark, Germany, Great Britain, Hong Kong, Indonesia, Italy, Korea, Kuwait, Malaysia, Netherlands, Nicaragua, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Romania, Serbia, Singapore, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, United Arab Emirates.",
      "recall_number": "Z-1310-2023",
      "product_description": "Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,",
      "product_quantity": "3285 boxes of 50 devices",
      "reason_for_recall": "Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a problem relating to a defective injection molded part which can limit the effectiveness of the syringe venting function which then can result in occlusion.",
      "recall_initiation_date": "20230224",
      "center_classification_date": "20230330",
      "report_date": "20230405",
      "code_info": "UDI di 10856038001048, Lot Numbers:  21K50N, exp. 11/30/2023; 22A03N, exp. 01/31/2024; 22A59N, exp. 2/29/2024; 22B54N, exp. 2/29/2024; 22D15N, exp. 4/30/2024; 22D28N, exp. 4/30/2024; 22D58N, exp. 4/30/2024; 22I17N, exp. 9/30/2024; 031851, exp. 9/30/2024; 22J46N, exp. 10/31/2024; 032198, exp. 11/30/2024; 22L02N,exp. 12/31/2024;  032822, exp. 1/31/2025"
    }
  ]
}