{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "216852",
      "product_res_number": "Z-0594-2026",
      "event_date_initiated": "2025-10-21",
      "event_date_posted": "2025-11-25",
      "recall_status": "Open, Classified",
      "res_event_number": "97873",
      "product_code": "PHV",
      "product_description": "CareLink Clinic, REF: MMT-7350",
      "code_info": "UDI-DI: 0763000B00008748K.\n\nSoftware Versions: 4.2B\n\nSoftware Available:\nUS: Between September 4th, 2025, and October 3rd, 2025.\nOUS: Between September 11th, 2025, and October 4th, 2025.\nUS (Clinical): Between August 21st, 2025, and October 3rd, 2025.\nOUS (Clinical): Between August 21st, 2025, and October 4th, 2025.",
      "firm_fei_number": "3003166194",
      "recalling_firm": "Medtronic MiniMed, Inc.",
      "address_1": "18000 Devonshire St",
      "city": "Northridge",
      "state": "CA",
      "postal_code": "91325-1219",
      "additional_info_contact": "Medtronic 24-Hr Technical Support\n800-646-4633",
      "reason_for_recall": "Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia.",
      "root_cause_description": "Software change control",
      "action": "On 10/21/2025, \"URGENT MEDICAL DEVICE CORRECTION\" notices were emailed to customers informing them of the following:  software version 4.2C was released to correct the issues with the data displayed on 24-hour Sensor Glucose Overview graph.\n\nIf you made individual diabetes treatment recommendations to patients based on the hypoglycemic patterns or on the 30-day sensor glucose data displayed on the 24-hour Sensor Glucose Overview graph with affected software, revisit those recommendations utilizing patients individual CareLink reports, as they were not impacted by this issue.\n\nComplete and return the confirmation form: https://info.medtronicdiabetes.com/carelink-clinic-dashboard-hcp or email form to rs.safetyinformation@medtronic.com\n\nFor questions, contact the firm's 24-Hour Technical Support line at 1-800-646-4633, option 9.",
      "product_quantity": "12126",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) including states of: TX, NC, MN, CA, VA, ID, WA, GA, MI, MA, OH, IL, IA, CT, FL, PA, NY, TN, AZ, LA, AL, NJ, CO, SC, MS, OR, MT, MD, KS, AK, NH, NE, WY, ND, IN, MO, WI, KY, UT, NV, SD, WV, NM, HI, AR, OK, VT, RI; and OUS (foreign) to countries of: Australia (AU), Sweden (SE), Belgium (BE), Great Britain (GB), Netherlands (NL), Finland (FI), Canada (CA), Germany (DE), Spain (ES), Switzerland (CH), Italy (IT), South Africa (ZA), South Korea (KR), Singapore (SG), New Zealand (NZ), Poland (PL), Israel (IL), Denmark (DK), Norway (NO), Luxembourg (LU), Lithuania (LT), Czech Republic ( CZ), Mexico (MX), Brazil (BR), Colombia (CO), Slovakia (SK), Ireland (IE), Argentina (AR), Greece (GR), Kuwait (KW), Portugal (PT), Iceland (IS), Japan (JP), Turkey (TR), Austria (AT), Qatar (QA), Hong Kong (HK), Chile (CL), Ukraine (UA), Hungary (HU), Estonia (EE), RS, Latvia (LV), Taiwan (TW), Saudia Arabia (SA), Bahrain (BH), Oman (OM), Romania (RO), India (IN), Uruguay (UY), Malaysia (MY), United Arab Emirates (AE), Algeria (DZ), Croatia (HR), France (FR), Russia (RU), Cyprus (CY), Thailand (TH), Egypt (EG), Bosnia and Herzegovina (BA), Libya (LY), and Iraq (IQ)",
      "openfda": {
        "k_number": [
          "DEN140016"
        ],
        "registration_number": [
          "3008770957",
          "3014585508",
          "3014642500",
          "2032227",
          "3024580094",
          "3009137498",
          "3012128418",
          "3016525500",
          "3004753838",
          "3028170577",
          "2954323",
          "3019004087",
          "3007981285",
          "3009862700",
          "3013922904",
          "3021611414"
        ],
        "fei_number": [
          "3008770957",
          "3014585508",
          "3014642500",
          "3024580094",
          "3009137498",
          "3012128418",
          "3016525500",
          "3004753838",
          "3028170577",
          "3002803444",
          "3019004087",
          "3007981285",
          "3003166194",
          "3009862700",
          "3013922904",
          "3021611414"
        ],
        "device_name": "Continuous Glucose Monitor Retrospective Data Analysis Software",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.2120",
        "device_class": "1"
      }
    }
  ]
}