{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Milpitas",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "96925",
      "recalling_firm": "BIGFOOT BIOMEDICAL",
      "address_1": "1820 Mccarthy Blvd",
      "address_2": "",
      "postal_code": "95035-7425",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide distribution in the states of AL, FL, GA, IA, IL, NY, PA, TX, and WA.",
      "recall_number": "Z-1997-2025",
      "product_description": "Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot Inject v1 Pen Cap RCAP Firmware 1.3.0 Release Configuration, Rev H  The Bigfoot Unity Diabetes Management System that include the Pen Caps (Rapid-Acting Insulin Pen Cap [RCAP] and Long-Acting Insulin Pen Cap [LCAP]) integrates continuous monitoring with insulin dose recommendations.  The Pen Caps (Rapid-Acting Insulin Pen Cap [RCAP] and Long-Acting Insulin Pen Cap [LCAP]) are part of the Bigfoot Unity Diabetes Management System.",
      "product_quantity": "57 pen caps",
      "reason_for_recall": "Due to a software/firmware issue diabetes management system may provide a device error and cause the insulin pen to become unresponsive and unable to function.  This error may pose a potential health risk for people living with diabetes as they may not have all information necessary to make a timely treatment decision.",
      "recall_initiation_date": "20250521",
      "center_classification_date": "20250620",
      "report_date": "20250702",
      "code_info": "Product Description / Item Number / UDI-DI code / Serial Number: Humalog/lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418  KR242250013 Lantus-Glargine Bigfoot Unity OMS Cap FG-300176 00850003506463  SL240720021 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449  FR242280004 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449  FR242280005 Fiasp Bigfoot Unity DMS Cap FG-300173 00850003506432  TR240950015 Lantus-Glargine Bigfoot Unity OMS Cap FG-300176 00850003506463  SL240720022 Levmr FlxT/Tresiba-Degl Bigfoot Unity OMS Cap FG-300179 00850003506494  TL242340007 Levmr FlxT/Tresiba-Degl Bigfoot Unity OMS Cap FG-300179 00850003506494  TL242340008 Humalog/lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418  KR242250014 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449  FR242280006 Levmr FlxT/Tresiba-Degl Bigfoot Unity OMS Cap FG-300179 00850003506494  TL242340010 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418  KR242250015 Lantus-Glargine Bigfoot Unity OMS Cap FG-300176 00850003506463  SL240720023 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418  KR242250016 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449  FR242280007 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418  KR242250017 Basaglar Bigfoot Unity OMS Cap FG-300175 00850003506456  FR242280009 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418  KR242250018 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418  KR242250020 Levmr FlxT/Tresiba-Degl Bigfoot Unity OMS Cap FG-300179 00850003506494  TL242340009 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449  FR242280008 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418  KR242250021 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449  KL241710001 Fiasp Bigfoot Unity OMS Cap FG-300173 00850003506432  TR241570002 Bigfoot Unity Cap for  Novolog ASM-10046* 00850003506173  FR242280014 Bigfoot Unity Cap for  Toujeo ASM-10053* 00850003506197  ST240960003 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449  FR242280010 Levmr FlxT/Tresiba-Degl Bigfoot Unity OMS Cap FG-300179 00850003506494  TL242340011 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449  FR242280011 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449  FR242280012 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418  KR242250022 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418  KR242250023 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418  KR242250026 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418  KR242250024 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418  KR242250025 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449  SL240720024 Lantus-Glargine Bigfoot Unity OMS Cap FG-300176 00850003506463  FR242280013 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449  FR242280018 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449  FR242280015 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418  KR242250029 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449  FR242280016 Fiasp Bigfoot Unity DMS Cap FG-300173 00850003506432  TR241570003 Humalog/Lispro/Lyumjev Bigfoot Unity DMS Cap FG-300171 00850003506418  KR242250030 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418  KR242250027 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418  KR242250028 Levmr FlxT/Tresiba-Degl Bigfoot Unity OMS Cap FG-300179 00850003506494  TL242340012 Lantus-Glargine Bigfoot Unity OMS Cap FG-300176 00850003506463  SL240720026 Fiasp Bigfoot Unity DMS Cap FG-300173 00850003506432  TR241570004 Lantus-Glargine Bigfoot Unity DMS Cap FG-300176 00850003506463  SL240720027 Novolog/Aspart Bigfoot Unity DMS Cap FG-300174 00850003506449  FR242280017 Novolog/Aspart Bigfoot Unity DMS Cap FG-300174 00850003506449  FR242280019 Fiasp Bigfoot Unity DMS Cap FG-300173 00850003506432  TR241570005 Humalog/Lispro/Lyumjev Bigfoot Unity DMS Cap FG-300171 00850003506418  KR242250031 Humalog/Lispro/Lyumjev Bigfoot Unity DMS Cap FG-300171 00850003506418  KR242250032 Humalog/Lispro/Lyumjev Bigfoot Unity DMS Cap FG-300171 00850003506418  KR242250033 Humalog/Lispro/Lyumjev Bigfoot Unity DMS Cap FG-300171 00850003506418  KR242250034 Lantus-Glargine Bigfoot Unity DMS Cap FG-300176 00850003506463  SL240720028",
      "more_code_info": ""
    }
  ]
}