{
  "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": {
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  "results": [
    {
      "cfres_id": "105222",
      "product_res_number": "Z-0357-2012",
      "event_date_initiated": "2011-10-14",
      "event_date_posted": "2011-12-02",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-03-08",
      "res_event_number": "60300",
      "product_code": "FCW",
      "k_numbers": [
        "K081477"
      ],
      "product_description": "Integra Surgical Luxtec MLX Light Source \nCatalog Numbers: 00MLXAU\n\n\nProduct Usage:  The Integra Luxtec MLX Light Source is designed to supply high intensity white light through a fiber optic cable for illumination of a surgical field during a surgical and or medical procedure.",
      "code_info": "SN'S: P0102211  P0102311  P0104611  P0104811  P0105011  P0105311  P0105411  P0105511  P0105911  P0106511  P0100311",
      "firm_fei_number": "3003418325",
      "recalling_firm": "Integra LifeSciences Corp.",
      "address_1": "311 Enterprise Dr",
      "city": "Plainsboro",
      "state": "NJ",
      "postal_code": "08536-3344",
      "additional_info_contact": "609-275-0500",
      "reason_for_recall": "A loose screw may result in shifting of components and improper function of the turret or actuator assembly.",
      "root_cause_description": "Process control",
      "action": "Integra  sent an URGENT: Field Corrective Action letter dated October 14, 2011 to all affected customers via FedEx.  The letter identified the affected product, the problem, and the actions to be taken with instructions to immediately inspect their inventory for potentially loose screws within the affected unit(s).  If the unit(s) were observed with loose screws, the unit(s) were to be returned to Integra Surgical for repair and servicing. Customers were instructed to complete the Acknowledgement and Return Form per the instructions on the form.  For questions call Integra Surgical Customer Service at 1-800-431-1123.",
      "product_quantity": "12",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) including the states of:  Arizona, California, Colorado, Florida, Indiana, Mississippi, New Jersey, New York, North Carolina, Ohio,   Pennsylvania, Montana, Washington, Wyoming, and Puerto Rico, and the countries of:  Australia, Germany, Italy, Japan, Netherlands, New Zealand, Pakistan,  Sweden, Switzerland, and Turkey.",
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        "device_name": "Light Source, Fiberoptic, Routine",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2",
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