{
  "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": "51068",
      "product_res_number": "Z-0703-2007",
      "event_date_initiated": "2007-02-19",
      "event_date_posted": "2007-04-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-06-27",
      "res_event_number": "37615",
      "product_code": "FAE",
      "k_numbers": [
        "K953640"
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      "product_description": "AMS DURA-II Universal Tips, 2cm, Product Number 72009361, Sterile, American Medical Systems, Inc. Minnetonka, MN",
      "code_info": "Lot 475175",
      "firm_fei_number": "1000116179",
      "recalling_firm": "American Medical Systems",
      "address_1": "10700 Bren Rd W",
      "city": "Minnetonka",
      "state": "MN",
      "postal_code": "55343-9679",
      "reason_for_recall": "Mis-Labeling:The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels.",
      "root_cause_description": "Other",
      "action": "The consignees were notified of the recall by letter starting Feb 7, 2007.  Consignees were asked to return product to American Medical Systems.",
      "product_quantity": "5 devices",
      "distribution_pattern": "Nationwide",
      "openfda": {
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        "device_name": "Prosthesis, Penile",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.3630",
        "device_class": "2",
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