{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "218863",
      "product_res_number": "Z-1996-2026",
      "event_date_initiated": "2026-03-12",
      "event_date_posted": "2026-04-29",
      "recall_status": "Open, Classified",
      "res_event_number": "98475",
      "product_code": "QFG",
      "k_numbers": [
        "K252770"
      ],
      "product_description": "iLet Bionic Pancreas, REF: BB1001",
      "code_info": "Software versions 1.4.3, and 1.4.2",
      "firm_fei_number": "3019004087",
      "recalling_firm": "Beta Bionics, Inc.",
      "address_1": "11 Hughes",
      "city": "Irvine",
      "state": "CA",
      "postal_code": "92618-1902",
      "additional_info_contact": "Karen Hynes\n855-745-3800",
      "reason_for_recall": "insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous\nGlucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses provided, no correction doses/insulin reductions/suspensions for high/low glucose unless blood glucose entered for\nsensor life or replacement. Potential health risks to users include severe hyperglycemia with and without DKA and severe hypoglycemia.",
      "root_cause_description": "Software change control",
      "action": "On 3/12/2026, correction notices were emailed to customers who were asked to do the following:\n\nUpdate device software to host software 1.4.4 and up.\nUpdate your software\n1. Download or update your iLet app on your phone.  Read the iLet App User Guide: https://www.betabionics.com/wp-content/uploads/LA000056_F-iLet-Mobile-App-User-Guide.pdf \n2. Log into your iLet app.\n3. Position your iLet next to your phone with the app open.\n4. Go to app settings on the iLet app and follow the on-screen instructions to update to the latest firmware.\n\n-Distributors are asked to provide patient contact information so the firm can provide the correction notice to these patients.\n\n- Complete the acknowledgment survey https://sprw.io/stt-6HnQU \nIf you have any questions, please call the firm's Customer Care at 1-855-745-3800 option 1.",
      "product_quantity": "1,080",
      "distribution_pattern": "US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.",
      "openfda": {
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        ],
        "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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