{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "29901",
      "product_res_number": "Z-0557-04",
      "event_date_initiated": "2003-06-30",
      "event_date_posted": "2004-02-27",
      "recall_status": "Terminated",
      "event_date_terminated": "2004-05-07",
      "res_event_number": "27452",
      "product_code": "FGO",
      "k_numbers": [
        "K001563"
      ],
      "product_description": "The device is SCIPRO Flexible Stone Dislodger and Retrieval Set, Catalog # SP3000146-ST used for removal of calculi, fragments of medical devices and other foreign objects uring urological or gatroenterological procedures.  The device has the manufacturer listed on the label which is Scion Cardio-Vascular, Inc., 14256 SW 119 Avenue, Miami, FL 33186.",
      "code_info": "Lot Number OML30522-01",
      "firm_fei_number": "1000113395",
      "recalling_firm": "Scion Cardio-Vascular, Inc.",
      "address_1": "14256 SW 119 Avenue",
      "city": "Miami",
      "state": "FL",
      "postal_code": "33186",
      "additional_info_contact": "Ramon Augusto Paz\n305-259-8880 Ext. 107",
      "reason_for_recall": "The firm received field complaints that it was difficult to open the stone retrieval basket during use.",
      "root_cause_description": "Other",
      "action": "The firm mailed a recall letter to there consignees on June 30, 2003 requesting return of any unused devices.  The firm has received 100% response and accounted for all recalled devices.",
      "product_quantity": "41",
      "distribution_pattern": "The software systems were installed at  2 medical centers in Illinois and Alabama.",
      "openfda": {
        "k_number": [
          "K962676",
          "K896322",
          "K001563",
          "K914112",
          "K970121",
          "K934598",
          "K951309",
          "K771302",
          "K922542",
          "K914110",
          "K963750",
          "K891253",
          "K914111",
          "K933261",
          "K893522",
          "K891252",
          "K895080",
          "K885168",
          "K921295"
        ],
        "registration_number": [
          "1519132",
          "3005987240",
          "3010041511",
          "3010202439",
          "1220477",
          "3010421104",
          "3007007790",
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          "3032859397",
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          "3011050570",
          "4486",
          "3003790304",
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          "2124215",
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        ],
        "device_name": "Dislodger, Stone, Flexible",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.4680",
        "device_class": "2"
      }
    }
  ]
}