{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "141455",
      "product_res_number": "Z-0394-2016",
      "event_date_initiated": "2015-11-02",
      "event_date_posted": "2015-12-15",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-03-07",
      "res_event_number": "72535",
      "product_code": "LZG",
      "k_numbers": [
        "K122953"
      ],
      "product_description": "OmniPod, Insulin Management System (OUS)\nCatalog Number: 14810 \n\nProduct Usage:\nThe OmnniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.",
      "code_info": "Lot Codes: L41908, L41910, F41935",
      "firm_fei_number": "3004464228",
      "recalling_firm": "Insulet Corporation",
      "address_1": "600 Technology Park Dr Ste 200 600 Technology Park Dr",
      "address_2": "Ste 200",
      "city": "Billerica",
      "state": "MA",
      "postal_code": "01821-4126",
      "additional_info_contact": "Same\n978-600-7000",
      "reason_for_recall": "Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.",
      "root_cause_description": "Process change control",
      "action": "Insulet issued  on 11/2/15 an URGENT: Field Safety Notification via Email notification and Federal Express. Letter describes the problem that certain lots of the pod's needle failed to deploy or there is a delay in the deployment of the needle.  \nCustomers not responding to the email or Federal Express will receive additional mailing and/or follow up phone calls.\nCall Customer Care at 1-855-407-3729 if you have any questions regarding this  Field Safety Notification.",
      "product_quantity": "5,179.0 boxes",
      "distribution_pattern": "Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.",
      "openfda": {
        "k_number": [
          "K160056",
          "K022831",
          "K030531",
          "K041318",
          "K042887",
          "K071613",
          "K021439",
          "K080639",
          "K111210",
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          "K032257",
          "K162296",
          "K253534",
          "K083225",
          "K143189",
          "K133593",
          "K111353",
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          "K993012",
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          "K993184",
          "K031541",
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          "K142619",
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          "K062323",
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          "K180045",
          "K240158",
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          "K020655",
          "K160482",
          "K040676",
          "K071788",
          "K043000",
          "K131294",
          "K122483",
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          "K090245",
          "K082595",
          "K160252",
          "K001604",
          "K063126",
          "K211575",
          "K042792",
          "K901588",
          "K100504",
          "K013309",
          "K905693",
          "K103825",
          "K021725",
          "K991376",
          "K022317",
          "K973044",
          "K122953",
          "K182630",
          "K223372",
          "K022394",
          "K884978",
          "K050312",
          "K031738"
        ],
        "registration_number": [
          "3002806818",
          "3006479639",
          "3001058982",
          "3011393376",
          "3016540876",
          "3015218509",
          "3007007790",
          "3020976354",
          "3014585508",
          "3008824097",
          "3007981285",
          "3042027705",
          "9610126",
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          "9617604",
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          "3009515470",
          "3012421607",
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          "9616814",
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          "2032227",
          "3007710663",
          "3010047442",
          "3027453514",
          "1220477",
          "3008810357",
          "3013636348",
          "2246552",
          "2029275",
          "3005627859",
          "3007871880",
          "3010291427",
          "1313700",
          "1721676"
        ],
        "fei_number": [
          "3002806818",
          "3006479639",
          "3003166194",
          "3011393376",
          "3001058982",
          "3016540876",
          "3015218509",
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          "3013756811",
          "1721676",
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          "3012421607",
          "3005340341",
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          "3008810357",
          "3013636348",
          "1000306431",
          "2246552",
          "3005627859",
          "3007871880",
          "3010291427",
          "3003024060",
          "1313700",
          "3002806559"
        ],
        "device_name": "Pump, Infusion, Insulin",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5725",
        "device_class": "2"
      }
    }
  ]
}