{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "196863",
      "product_res_number": "Z-0423-2023",
      "event_date_initiated": "2022-11-14",
      "event_date_posted": "2022-12-07",
      "recall_status": "Open, Classified",
      "res_event_number": "91127",
      "product_code": "QFG",
      "k_numbers": [
        "K203768"
      ],
      "product_description": "Omnipod 5 Automated Insulin Delivery System\nProduct catalog numbers:\nPT-000409: ASM, Omnipod 5, PDM, Programmed\nPT-000428: Adaptor, Charging, Noetic Nuu N5004L, Horizon PDM, US\nPT-000429: Cable, Charging, Omnipod 5, Horizon PDM",
      "code_info": "ALL serial numbers/ controller lots are currently in scope of this recall",
      "firm_fei_number": "3014585508",
      "recalling_firm": "Insulet Corporation",
      "address_1": "100 Nagog Park",
      "city": "Acton",
      "state": "MA",
      "postal_code": "01720-3440",
      "additional_info_contact": "Insulet Customer Care\n800-641-2049",
      "reason_for_recall": "The firm has become aware of an issue with the Omnipod 5 Controller where the Controller charging port and charging cable are melting, deforming, or discoloring due to heat generated by increased resistance in the Controller port. The excess heat may cause minor burns if touched, and the Omnipod 5 Controller may fail to charge, requiring the user to switch to their backup insulin plan.",
      "root_cause_description": "Device Design",
      "action": "On November 14, 2022, the firm initiated their Press Release at https://investor.insulet.com/news-releases/news-release-details/insulet-issues-nationwide-voluntary-medical-device-correction and notified affected customers through Urgent Medical Device Correction letters.\n\nCustomers were instructed to monitor their Omnipod 5 Controller for the following issues: \n\n- Charging port or charging cable appears melted, deformed, or discolored\n- Controller experiences extreme overheating (uncomfortable to hold) or emits an odor while charging\n\nIf customers experience any of the issues above, they should disconnect the charger from the power outlet and do NOT charge the Omnipod 5 Controller. \n\nPromptly contact Insulet s dedicated Customer Care team specifically trained to help you at 1-800-641-2049 to request a replacement device. If you have a compatible Android smartphone (please see omnipod.com/compatibility), you may want to switch to using the Omnipod 5 App on your smartphone.\n\nCustomers were provided with additional precautions to take to continue use of the device.",
      "product_quantity": "129,086",
      "distribution_pattern": "Domestic distribution nationwide.",
      "openfda": {
        "k_number": [
          "K203234",
          "K213536",
          "K230545",
          "K253743",
          "K253074",
          "K203768",
          "K250792",
          "K253470",
          "K223213",
          "K241078",
          "K234027",
          "K232380",
          "K233952",
          "K261672",
          "K231485",
          "K253976",
          "K201214",
          "K213134",
          "K241178",
          "K250930",
          "K223846",
          "K191679",
          "DEN180058",
          "K252770",
          "K233044",
          "K231826",
          "K251032",
          "K240309"
        ],
        "registration_number": [
          "3016798778",
          "3047799708",
          "2030598",
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        ],
        "fei_number": [
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          "3026266833",
          "1000518731",
          "3003058448",
          "3010291427",
          "3030970576",
          "3013756811"
        ],
        "device_name": "Alternate Controller Enabled Insulin Infusion Pump",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "880.5730",
        "device_class": "2"
      }
    }
  ]
}