{
  "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": "104989",
      "product_res_number": "Z-0356-2012",
      "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: 00MLX\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:  P0103111  P0105711  P0106011 P0200111  P0200211  P0201111   P0201611  P0201811  P0202011 P0202111  P0202911   P0203111  P0203411  P0203711 P0203811  P0204011  P0204211  P0204311 P0204411  P0204611    P0204711  P0204811  P0204911  P0205211  P0205411  P0205511  P0205711  P0205611  P0205811   P0205911  P0206211  P0206311  P0206411  P0210711  P0212911  P0213811   P0213911  P0300211  P0300411  P0300711  P0300911  P0301011  P0301411  P0301511  P0301711   P0301811  P0302111  P0302311 P0302411   P0302511  P0302611  P0302711  P0302811  P0303011  P0303111  P0303211  P0303311  P0303511  P0303611  P0303711  P0304011  P0304111  P0304311  P0304411 P0304611",
      "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": "66 units",
      "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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