{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Irvine",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "98528",
      "recalling_firm": "Beta Bionics, Inc.",
      "address_1": "11 Hughes",
      "address_2": "N/A",
      "postal_code": "92618-1902",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, LA, MA, MD, ME, MI, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WY AND WASHINGTON DC.",
      "recall_number": "Z-1809-2026",
      "product_description": "iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software",
      "product_quantity": "15 units",
      "reason_for_recall": "it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar that are active, thereby allowing the user to bypass those screens when those icons on the status bar are pressed, allowing unauthorized access while the device is in Limited Access Mode. A Health Risk associated with Limited access mode includes severe hypoglycemia due to unauthorized access to the iLet if someone were to make unauthorized meal announcements or stopped insulin delivery.",
      "recall_initiation_date": "20250813",
      "center_classification_date": "20260410",
      "report_date": "20260422",
      "code_info": "ILet Ace Pumps containing software version BOM000036 Rev C (version 1.4.2) or older."
    }
  ]
}