{
  "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": "105223",
      "product_res_number": "Z-0358-2012",
      "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: 00MLXEU",
      "code_info": "SN'S: P0102011  P0203911  P0204511  P0302011  P03011211  P0303411  P0104911 P0105211  P0105811  P0106611",
      "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": "19",
      "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.",
      "openfda": {
        "k_number": [
          "K012265",
          "K123359",
          "K992447",
          "K760647",
          "K970598",
          "K905376",
          "K082813",
          "K081477",
          "K903790",
          "K890716",
          "K963043",
          "K760176",
          "K993300",
          "K852951",
          "K945420",
          "K091968",
          "K832807",
          "K000229",
          "K121724",
          "K934531",
          "K942155",
          "K864385",
          "K093792",
          "K842609",
          "K131226",
          "K964586",
          "K951647",
          "K771739",
          "K123956",
          "K933369",
          "K032430"
        ],
        "device_name": "Light Source, Fiberoptic, Routine",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2",
        "registration_number": [
          "3006973663",
          "9610617",
          "2936485",
          "3006765019",
          "3010707607",
          "3009656988",
          "3011277660",
          "1221934",
          "2434839",
          "3003782610",
          "3006546082",
          "3003418325",
          "9610877",
          "1017294",
          "1319480",
          "9611274",
          "9611102",
          "9615782",
          "3013247477",
          "3011050570",
          "3014334038",
          "3006697299",
          "3012322232",
          "9614209",
          "3004464325",
          "9680718",
          "3014342096",
          "2518897",
          "3008569850",
          "1035968",
          "3008114965",
          "3015612252",
          "3016832577",
          "3008868758",
          "9612074",
          "3013868968",
          "3012507533",
          "3010202439",
          "1222275",
          "8043903",
          "1833053",
          "2085947",
          "3015532525",
          "3007137643",
          "3002807314",
          "3011676349",
          "3010120217",
          "3004215117",
          "3011063460",
          "3007305485",
          "3005809810",
          "1320894",
          "3010885402",
          "1221826",
          "1421101",
          "2020550",
          "3014644276",
          "3007303113",
          "3006984716",
          "3013002167",
          "3008837339",
          "3004001706",
          "3014279513"
        ],
        "fei_number": [
          "3006973663",
          "2936485",
          "1000120295",
          "3007305485",
          "3006765019",
          "3010707607",
          "3009656988",
          "3011277660",
          "3008185830",
          "1221934",
          "3002808268",
          "2434839",
          "3003782610",
          "3006546082",
          "3003418325",
          "3007475226",
          "3002808043",
          "1017294",
          "3013247477",
          "3001451571",
          "3011050570",
          "3014334038",
          "3002807072",
          "3000204191",
          "3006697299",
          "3004084693",
          "3012322232",
          "3004464325",
          "3002808088",
          "3014342096",
          "3008569850",
          "1035968",
          "3008114965",
          "3015612252",
          "3016832577",
          "3008868758",
          "3013868968",
          "3012507533",
          "1833053",
          "3002806725",
          "3006149253",
          "3002807314",
          "3011676349",
          "3010120217",
          "3015532525",
          "3011063460",
          "3004215117",
          "1000121058",
          "3007137643",
          "3010885402",
          "3005809810",
          "1221826",
          "1000080301",
          "1421101",
          "2020550",
          "3002808001",
          "3007303113",
          "3006984716",
          "3013002167",
          "3008837339",
          "3004001706",
          "3014279513",
          "3000280067"
        ]
      }
    }
  ]
}