{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Kennesaw",
      "state": "GA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "82625",
      "recalling_firm": "Dornier Medtech America, Inc.",
      "address_1": "1155 Roberts Blvd NW",
      "address_2": "N/A",
      "postal_code": "30144-3600",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "US Nationwide distribution.",
      "recall_number": "Z-1381-2019",
      "product_description": "Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers  Part Number/Description:  K1001291 600 micron single use fiber  K2011824 600 micron single use fiber  K1001293 600 micron single use fiber  K2011826 600 micron 5X reusable fiber  K1008084 600 micron single use fiber  K2011828 400 micron 5X reusable fiber  K1010500 600 micron fibertome fiber  K2012021 600 micron single use fiber  K1015640 AngioSpot Fiber Kit  K2012393 600 micron single use fiber  K2010292 400 micron single use fiber  K2012439 600 micron 5X reusable fiber  K2010667  micron ITT fiber  K2012875 600 micron 3X reusable fiber  K2010710 400 micron single use fiber  K2012879 400 micron 3X reusable fiber  K2011822 400 micron single use fiber  Product Usage: The Dornier Diode Fibers are accessories to the Dornier Medilas D Family Lasers. The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT, and Radiology. The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse. and Medilas D MagnaPulse, are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (tumors) and removal of unwanted hair, for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux and treatment of reticular veins and branch varicosities. The Dornier Medilas D Family Lasers, specifically the Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 28-85 cc.",
      "product_quantity": "400 units",
      "reason_for_recall": "Pin hole package failures compromising sterility of product",
      "recall_initiation_date": "20190401",
      "center_classification_date": "20190521",
      "termination_date": "20200420",
      "report_date": "20190529",
      "code_info": "All lot numbers"
    }
  ]
}