{
  "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,
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  "results": [
    {
      "cfres_id": "106491",
      "product_res_number": "Z-0749-2012",
      "event_date_initiated": "2011-12-21",
      "event_date_posted": "2012-01-13",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-05-10",
      "res_event_number": "60798",
      "product_code": "HBG",
      "k_numbers": [
        "K961113"
      ],
      "product_description": "Cranial Access Kit Ref INSHITH Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile, (1) Lidocaine 1.5% w/ Epinephrine (30 ml VIAL). Sterile EO, Contents 5 units.  \n\n\nProduct Usage:  The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations.",
      "code_info": "W1001285, W1001313, W1002070, W1003048, W1003050, W1003228, W1004005, W1004275, W1004090, W1005002,, W1006124, W1005003, W1006125, W1007156, W1007157, W1007160, W1007161, W1008142, W1008143, W1008144, W1008145, W1009295, W1010034, W1010035, W1010085, W1010086, W1012248, W1012249, W1012250, W1101101, W1101102, W1101103, W1102113, W1102114, W1103150, W1103193, W1103192, W1103194, W1105094, W1105095, W1105096, W1108087, W1108190, W1108192, W1108191, W1108193, W1108194, W1109005, W1109006, W1109007, W1110170.",
      "firm_fei_number": "1000138491",
      "recalling_firm": "Integra LifeSciences Corp. d.b.a. Integra Pain Management",
      "address_1": "3498 West 2400 South #1050 3498 West 2400 South",
      "address_2": "#1050",
      "city": "Salt Lake City",
      "state": "UT",
      "postal_code": "84119",
      "additional_info_contact": "801-886-9505",
      "reason_for_recall": "Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.",
      "root_cause_description": "Labeling False and Misleading",
      "action": "Integra sent an Urgent: Medical Device Correction Notice letter dated December 21, 2011 to all affected customers.  The letter identified the product, problem and actions to be taken.  Integra is requesting that customers further distribute the communications along with the package insert to all appropriate  health care practitioners at their facility.  The letter instructs customers to complete and return the attached acknowledgement form by fax to 609-750-7999.  For questions or concerns call 609-750-2814.",
      "product_quantity": "24690 units",
      "distribution_pattern": "(USA) Nationwide Distribution",
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