{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "215511",
      "product_res_number": "Z-0232-2026",
      "event_date_initiated": "2025-08-05",
      "event_date_posted": "2025-10-23",
      "recall_status": "Open, Classified",
      "res_event_number": "97403",
      "product_code": "QFG",
      "k_numbers": [
        "K201214",
        "K203234",
        "K240309",
        "K241078"
      ],
      "product_description": "t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexcom G7 sensor;\nTandem Mobi insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014801, 1014811, 1014813, and User Guide when using Dexcom G7 sensor",
      "code_info": "t:slim X2, UDI-DI: 00389152407012, 00389152407111, 00389152407210, 00389152407319 with software versions 7.9.0.1 and 7.10.1, User Guide versions not including and prior to: AW-1014562 Revision D;\n\nTandem Mobi, UDI-DI: 00389152480114, 00389152481111, 00389152481319\n with software version 7.9.0.1, User Guide versions not including and prior to: AW-1014938 Revision C",
      "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\n858-366-6880",
      "reason_for_recall": "A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1 of the Tandem Mobi pump with Control-IQ+ technology that are paired with a G7 sensor may result in an unexpected automatic insulin correction bolus (autobolus ) which could result in hypoglycemia.",
      "root_cause_description": "Software change control",
      "action": "On 8/5/2025, Field Safety Notices were sent to customers informing them of the following:\nActions to avoid the issue:\n- Wait until your G7 sensor session ends before inserting a new G7 sensor.\n- However, if you do insert a new G7 sensor before your last sensor session ends, wait to pair until at least 20 minutes after the last session ends.\n\nFirm is working on a software update to resolve this issue. If you have questions or need help, please call firm's Customer Support 1-877-801-6901 or email Techsupport@tandemdiabetes.com. Our team is available 24/7/365.\n\nOn 9/16/2025, correction notices were emailed to customers who were informed the firm updated user guides to align with instructions in the correction notice.  Also, the firm will notify impacted users via an updated Field Correction Notice when the software update is available.  The notice will provide instructions on how to remotely update their software.",
      "product_quantity": "122,958",
      "distribution_pattern": "US nationwide distribution including Puerto Rico.",
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        ],
        "device_name": "Alternate Controller Enabled Insulin Infusion Pump",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "880.5730",
        "device_class": "2",
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