{
  "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": "2026-09-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "cfres_id": "221440",
      "product_res_number": "Z-2980-2026",
      "event_date_initiated": "2026-07-13",
      "event_date_posted": "2026-08-18",
      "recall_status": "Open, Classified",
      "res_event_number": "99374",
      "product_code": "QFG",
      "k_numbers": [
        "K251032"
      ],
      "product_description": "MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;",
      "code_info": "Model/UDI-DI/Serial Numbers:\nMMT-1711/00763000404550/NG2660048H, NG2663343H, NG3015306H;\n\nMMT-1712/00763000404567/NG2628486H, NG2758213H, NG2999651H, NG3349198H, NG3351719H, NG2678842H, NG2831821H, NG2831546H, NG2932027H, NG3049657H, NG3033094H, NG2831538H, NG3738739H",
      "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": "Ashley Patterson\n800-646-4633",
      "reason_for_recall": "Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.",
      "root_cause_description": "Process design",
      "action": "On 7/13/2026, field safety notices were sent to customers asking them to do the following:\n1) Stop using the loaner pump and contact the firm to arrange for loaner pump return. \n2) Contact your Healthcare Professional (HCP) to ensure you have access to backup insulin therapy supplies or alternative plans, which may include short- and long-acting insulins, syringes, with dosage instructions from your HCP.\n3) Complete and return the customer acknowledgement form.\n\nQuestions can be directed to the firm's Tech Support: 1-800-646-4633",
      "product_quantity": "16",
      "distribution_pattern": "International distribution to the countries of Germany, Denmark, Austria, Netherlands, United Kingdom, Italy, Belgium, Ireland, Switzerland, Sweden, Northern Ireland.",
      "openfda": {
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          "K231485",
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          "K241178",
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          "K253074",
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        "registration_number": [
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        "fei_number": [
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          "3044561902",
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          "3005627859",
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        ],
        "device_name": "Alternate Controller Enabled Insulin Infusion Pump",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "880.5730",
        "device_class": "2"
      }
    }
  ]
}