{
  "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": "31275",
      "product_res_number": "Z-0588-04",
      "event_date_initiated": "2003-12-19",
      "event_date_posted": "2004-07-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-04-06",
      "res_event_number": "28148",
      "product_code": "GXQ",
      "product_description": "EnDura No-React Dural Substitute.  Product comes in different sizes (2x10, 4x4, 5x6, 6x10, 10x12, and 12 cm diameters), sterile, stored in 2% benzyl alcohol, and distributed by Integra NeuroSciences, Plainsboro, NJ  08536.",
      "code_info": "Lot#, Catalog #, Description:  030911-NR, ENR-20210, 2CM X 10CM; 030911-NR, ENR-20404, 4CM X 4CM; 030911-NR, ENR-20506, 5CM X 6CM; 030808-NR, ENR-20610, 6CM X 10CM; 030811-NR, ENR-20610, 6CM X 10CM; 030911-NR, ENR-21012, 10CM X 12CM; 030924-NR, ENR-21012, 10CM X 12CM; 031027-NR, ENR-21212, 12CM Diameter.",
      "firm_fei_number": "1000081147",
      "recalling_firm": "Shelhigh Inc",
      "address_1": "650 Liberty Ave",
      "city": "Union",
      "state": "NJ",
      "postal_code": "07083-8130",
      "additional_info_contact": "Dr. Shlomo Gabbay\n908-206-8706",
      "reason_for_recall": "The tamper-evident shrink band may fall off causing the user uncertainty whether the product was opened and is still sterile.",
      "root_cause_description": "Other",
      "action": "Letter was sent 12/19/2003 to the 19 hospitals were the product was distributed.",
      "product_quantity": "1002 units",
      "distribution_pattern": "The product is distributed natiowide to 19 different hospitals.",
      "openfda": {
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        "registration_number": [
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        ],
        "device_name": "Dura Substitute",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.5910",
        "device_class": "2"
      }
    }
  ]
}