{
  "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": "2026-10-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "212816",
      "product_res_number": "Z-1519-2025",
      "event_date_initiated": "2025-02-27",
      "event_date_posted": "2025-04-11",
      "recall_status": "Open, Classified",
      "res_event_number": "96417",
      "product_code": "QFG",
      "k_numbers": [
        "K232380"
      ],
      "product_description": "t:slim X2 Insulin Pump with Interoperable Technology",
      "code_info": "Software versions 7.9/UDI: 00389152407012",
      "firm_fei_number": "3007981285",
      "recalling_firm": "Tandem Diabetes Care, Inc.",
      "address_1": "12400 High Bluff Dr",
      "city": "San Diego",
      "state": "CA",
      "postal_code": "92130-3077",
      "additional_info_contact": "Ms. Susan Morrison\n877-801-6901",
      "reason_for_recall": "A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.",
      "root_cause_description": "Software Design Change",
      "action": "On  February 28, 2025 Tandem Diabetes Care  contacted each affected customer by phone concerning a Urgent Medical Device Correction.  On March 11, 2025, Tandem followed up with a \"Urgent Medical Device\" Recall notification via E-Mail to affected consignees. Tandem ask consignees to take the following action: \n\n1.\tTurn off Control-IQ+ immediately. You may continue to use your pump without Control-IQ active. Your pump will deliver insulin based on your programmed active personal profile and will not automatically adjust insulin delivery.\n2. Please refer to the user guide provided with your pump for more detailed instructions.\n3.\tContinue using your Tandem pump as described in the User Guide.\n4.\tPay attention to all system alerts and alarms.\n5.\tAlways carry back-up supplies.",
      "product_quantity": "63 units",
      "distribution_pattern": "US: AZ, CA, CO, CT, FL, HI, IA, ID, IL, IN, MD, ME, MI, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, PA, TX, UT, VA, WA, WI\nOUS: N/A",
      "openfda": {
        "k_number": [
          "K241178",
          "K253743",
          "K231485",
          "K252770",
          "K250930",
          "K233044",
          "K261672",
          "K240309",
          "K234027",
          "K203234",
          "K253470",
          "K213536",
          "K241078",
          "K230545",
          "DEN180058",
          "K232380",
          "K191679",
          "K231826",
          "K203768",
          "K253976",
          "K253074",
          "K251032",
          "K213134",
          "K250792",
          "K223213",
          "K201214",
          "K233952",
          "K260001",
          "K223846"
        ],
        "device_name": "Alternate Controller Enabled Insulin Infusion Pump",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "880.5730",
        "device_class": "2",
        "registration_number": [
          "3014585508",
          "3007981285",
          "3042027705",
          "3026266833",
          "3015192982",
          "2032227",
          "3044561902",
          "2246552",
          "3008824097",
          "3014197758",
          "2032098",
          "3019807891",
          "2029275",
          "2030598",
          "3005627859",
          "2030624",
          "3010291427",
          "3016540876",
          "1220973",
          "3032746481",
          "3016245399",
          "3047799708",
          "3016798778",
          "1220477",
          "3013756811",
          "2024024",
          "3019004087",
          "3030970576",
          "2022435"
        ],
        "fei_number": [
          "3014585508",
          "3007981285",
          "3042027705",
          "3026266833",
          "3015192982",
          "1000518731",
          "3044561902",
          "2246552",
          "3008824097",
          "3003058448",
          "3014197758",
          "3019807891",
          "3003166194",
          "3005627859",
          "3000206435",
          "1000306431",
          "3010291427",
          "3016540876",
          "1220973",
          "3032746481",
          "3016245399",
          "3047799708",
          "3016798778",
          "1220477",
          "3013756811",
          "2024024",
          "3019004087",
          "3030970576",
          "2022435"
        ]
      }
    }
  ]
}