{
  "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": "170857",
      "product_res_number": "Z-0177-2020",
      "event_date_initiated": "2018-08-07",
      "event_date_posted": "2019-11-04",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-03-29",
      "res_event_number": "82078",
      "product_code": "LZG",
      "k_numbers": [
        "K990801"
      ],
      "product_description": "Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE, MMT-500RCH, MMT-500RDE, MMT-500REU, MMT-500RFR, MMT-500RGB, MMT-500RIL, MMT-500RNL) for use with the MiniMed 508 Insulin Pump (MMT-508).",
      "code_info": "All serial numbers",
      "firm_fei_number": "3003166194",
      "recalling_firm": "Medtronic Inc.",
      "address_1": "18000 Devonshire St",
      "city": "Northridge",
      "state": "CA",
      "postal_code": "91325-1219",
      "additional_info_contact": "Pamela Reese\n818-576-3398",
      "reason_for_recall": "There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps.",
      "root_cause_description": "Software design",
      "action": "Medtronic sent an Urgent Field Safety Notification letter dated August 7, 2018 to the patient, distributor, and healthcare provider via email, U.S. mail, or phone.  The letter identified the affected product, problem and actions to be taken.\n\nStarting on 10/05/2021, recall notices were sent to patients, health care professionals, distributors, and personnel at clinical sites. Distributors were asked to provide their customer lists to the recalling firm so the recalling firm could send customers recall notices. The scope of the recall is being expanded to all users regardless of warranty status. Users are asked to stop using and disconnect the remote controller, disable the remote feature, and return the remote controller to the recalling firm. Customers were also asked to provide the information requested in the confirmation form to the recalling firm via phone, mail, email, or online on the firm's website. Additional questions can be directed to Technical Support at 1-800-378-2292. Disconnecting/Disabling instructions were provided in the recall notice, which provided the following link: https://info.medtronicdiabetes.com/remote-controller-return",
      "product_quantity": "90,213",
      "distribution_pattern": "Distribution was nationwide to consumers and distributors.  There was no government/military distribution.  \n\nForeign distribution was made to Algeria, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Denmark, Estonia, Faroe Islands, Finland, France, Germany, Greece, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Martinique, Namibia, Netherlands, New Caledonia, Norway, Oman, Pakistan, Poland, Reunion, Romania, Russian Federation, Saudi Arabia, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, and United Kingdom.",
      "openfda": {
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          "K100504",
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          "K131294",
          "K013807",
          "K253534",
          "K905693",
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          "K062323",
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          "K160252",
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          "K241622",
          "K143189",
          "K111210",
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          "K032257",
          "K142619",
          "K030531",
          "K180045",
          "K032164",
          "K050312",
          "K993012",
          "K043000",
          "K063126",
          "K093364",
          "K994186",
          "K013309",
          "K040676",
          "K031738",
          "K080639",
          "K182630",
          "K042873",
          "K022394"
        ],
        "registration_number": [
          "3010291427",
          "3012421607",
          "2029275",
          "3013636348",
          "3007007790",
          "3014585508",
          "3009515470",
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          "3013756811",
          "2246552",
          "9616814",
          "3009337401",
          "3020976354",
          "3015218509",
          "3008824097",
          "3006479639",
          "3010162782",
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        "fei_number": [
          "3010291427",
          "3012421607",
          "3013636348",
          "3007007790",
          "3003166194",
          "3014585508",
          "3009515470",
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          "3020976354",
          "3015218509",
          "3008824097",
          "3006479639",
          "3010162782",
          "3002558692",
          "3005340341"
        ],
        "device_name": "Pump, Infusion, Insulin",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5725",
        "device_class": "2"
      }
    }
  ]
}