{
  "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,
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  "results": [
    {
      "cfres_id": "213511",
      "product_res_number": "Z-0033-2026",
      "event_date_initiated": "2025-05-07",
      "event_date_posted": "2025-10-02",
      "recall_status": "Open, Classified",
      "res_event_number": "96745",
      "product_code": "MDS",
      "pma_numbers": [
        "P160007"
      ],
      "product_description": "Medtronic, Simplera Sensor, REF: MMT-5100JD1",
      "code_info": "Lot # HG81GLZ/ GTIN: 20763000649580",
      "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. Tech Support\n1800-646-4633 Ext. 1",
      "reason_for_recall": "The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.",
      "root_cause_description": "Process design",
      "action": "On May 7, 2025, Medtronic issued a \"Urgent Field Safety Notice\"  to affected consignees. Medtronic asked consignees to take the following actions: \n\n1. Verify if the sensors you currently have are from the impacted lot.\n\n2. If you have a Simplera\" sensor from the impacted lot, do not use this Simplera\" sensor and dispose of it according to local regulations.\n\n\n3. Please contact our helpline/your Medtronic contact at 01923 205167 to request a replacement.\n\n4. Please acknowledge that you have read and understood this notification and have followed the actions listed in this letter, even if your sensor is unaffected, or if you do not have any sensors from the affected lot.",
      "product_quantity": "1,440 units",
      "distribution_pattern": "US: No distribution \nOUS: Austria, Belgium, Italy, Spain, Switzerland, United Kingdom",
      "openfda": {
        "pma_number": [
          "P120005",
          "P150029",
          "P120010",
          "P160007",
          "P980022",
          "P050012",
          "P140015",
          "P150019",
          "P050020",
          "P130007",
          "P150021"
        ],
        "registration_number": [
          "3009882464",
          "3002807314",
          "3007527549",
          "3007939342",
          "9710492",
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          "3013756811",
          "3010893867",
          "3004139819",
          "3004173703",
          "3006371704"
        ],
        "device_name": "Sensor, Glucose, Invasive",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}