{
  "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": "161306",
      "product_res_number": "Z-0557-2018",
      "event_date_initiated": "2017-08-07",
      "event_date_created": "2018-02-09",
      "recall_status": "Open, Classified",
      "res_event_number": "79075",
      "product_code": "NEY",
      "k_numbers": [
        "K133821"
      ],
      "product_description": "Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm (reinforced), Material CA15L2",
      "code_info": "UDI 10884521706583, Lot codes: S6MG005PX,S6MG008PX,S6MG012PX,S6MG019PX,S7AG001PX,S7AG006X,S7AG010X,S7AG013X,S7BG001X,S7BG003X,S7BG007X,S7BG013X,S7CG002X,S7CG005X,S7CG007X,S7CG013X,S7EG009X,S7FG003X,S7FG004X,S7FG007X",
      "firm_fei_number": "1219930",
      "recalling_firm": "Covidien LLC",
      "address_1": "60 Middletown Ave",
      "city": "North Haven",
      "state": "CT",
      "postal_code": "06473-3908",
      "additional_info_contact": "203-492-5000",
      "reason_for_recall": "The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.",
      "root_cause_description": "Device Design",
      "action": "All consignees were notified via Federal Express or certified mail on August 7, 2017, and the letter informs customers of the possible trocar tip disengagement and the actions they should take. Customers are requested to segregate and return affected product and acknowledge receipt and understanding of the Urgent Medical Device Recall Notice.",
      "distribution_pattern": "Nationwide including PR, Canada, China",
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        "device_name": "System, Ablation, Microwave And Accessories",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4400",
        "device_class": "2"
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