{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Bloomington",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "69417",
      "recalling_firm": "Cook Medical Incorporated",
      "address_1": "400 N Daniels Way",
      "address_2": "N/A",
      "postal_code": "47404-9155",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution-USA (nationwide) including the states of Arizona, California, Colorado, Hawaii, Iowa, Illinois, Massachusetts, Maryland, Michigan, Missouri, New Mexico, Pennsylvania, Texas, Virginia, Vermont, and Wisconsin, and the countries of AT; BE; CH; CY; CZ; DE; DK; ES; FI; FR; GB; HU; IC; IE; IS; IT; LB; LT; LU; NL; NO; PT; QA; SE; TR; and ZA.",
      "recall_number": "Z-0124-2015",
      "product_description": "Spirotome\" Soft-Tissue Biopsy Needle Set.    The Spirotome Biopsy Needle Set includes a two-part introducer needle that consists of a cutting cannula and a trocar stylet, a helical-tip biopsy needle that has been sized to fit through the lumen of the cutting cannula. The Spirotome Biopsy Needle Set is intended for percutaneous acquisition of soft tissue specimens for laboratory analysis.",
      "product_quantity": "1239 units",
      "reason_for_recall": "MEDINVENTS, the manufacturer of the Spirotome" Soft-Tissue Biopsy Needle Set distributed by Cook Medical, has initiated a voluntary recall of these products.  The recall has  been initiated due to customer complaints that the protective caps were dislodged in the pouch. Further  investigation disclosed potential dislodging of protective caps on the needle tips on other distributed  products.",
      "recall_initiation_date": "20140926",
      "center_classification_date": "20141024",
      "termination_date": "20160202",
      "report_date": "20141105",
      "code_info": "Model Numbers:  SS-08-06; SS-08-10; SS-08-15; SS-10-06; SS-10-10;   SS-10-15; SS-14-06; SS-14-10; SS-14-15.     Lot numbers:  P030214C; P020413A; P190813B; P020413B; P030214A;  P020413F; P300913A; P020413D; P190813D; P030214B;  P020413E; P190813F; P300913B; P020413C; P190813E.",
      "more_code_info": ""
    }
  ]
}