{
  "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": "2026-10-24",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
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  },
  "results": [
    {
      "cfres_id": "221918",
      "product_res_number": "Z-3330-2026",
      "event_date_initiated": "2026-07-16",
      "event_date_posted": "2026-09-29",
      "recall_status": "Open, Classified",
      "res_event_number": "99589",
      "product_code": "QFG",
      "k_numbers": [
        "K201214",
        "K203234",
        "K232380"
      ],
      "product_description": "Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13 Software Version: iOS software version 2.13 UDI-DI: 00389152470740 Component: No",
      "code_info": "Lot Code: UDI-DI: 00389152470641\nSoftware Version: 2.13 (iOS only)",
      "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": "Susan Morrison\n1-858-3666880",
      "reason_for_recall": "A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott FreeStyle Libre 3 Plus (FSL3P) continuous glucose monitoring (CGM) sensors, resulting in the insulin pump being unable to establish a near-field communication (NFC) connection with the CGM and requiring FSL3P users to use their t:slim insulin pumps in manual mode. FSL3P users are unable to access their CGM's glucose values from within the t:slim app and cannot use their pumps in automated control (closed-loop) mode, which could lead to users experiencing hypoglycemia or hyperglycemia.",
      "root_cause_description": "Software Design Change",
      "action": "On 07/16/2026, an \"URGENT MEDICAL DEVICE CORRECTION\" communication was sent via certified mail to customers informing them that an unexpected behavior was identified in the t:slim iOS mobile application version 2.13 made available through TestFlight.  The issue involves users unable to pair a compatible FreeStyle Libre 3 Plus sensor after updating to version 2.13.  If this occurs, the application will incorrectly display an \"Incompatible Sensor\" message and prevent sensor use.\n\nCustomer are advised to:\n1. Discontinue use of iOS t:slim mobile application version 2.13\n2. Uninstall version 2.13 from their mobile device.\n3. Return to the current production version of the t:slim mobile application (version 2.12.1) available on the Apple App Store.\n4. Scan the compatible FreeStyle Libre 3 Plus sensor with version 2.12.1 when starting their next sensor session.\n\nFor Questions - contact Tandum Customer Support at 1-877-801-6901 or email Techsupport@tandumdiabetes.com (24/7/365).",
      "product_quantity": "177",
      "distribution_pattern": "US Nationwide distribution.",
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          "K213134",
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          "K240309",
          "DEN180058"
        ],
        "device_name": "Alternate Controller Enabled Insulin Infusion Pump",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "880.5730",
        "device_class": "2",
        "registration_number": [
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