{
  "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": "Irvine",
      "state": "CA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80812",
      "recalling_firm": "Endologix",
      "address_1": "35 Hammond",
      "address_2": "",
      "postal_code": "92618-1607",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S.:  PA, VA, CA, AZ, IN, GA, FL, IL, OK, MN, OH, KY, MS, NC, MI, AL, CT, LA, SC, TN, NY, WI, MD, WV, AR, NV, NJ, TX, CO, NE, NM, MA, IA, AK, OR, ME, SD, MO, MT, KS, DE, WA, UT, NH, ND, DC, RI, HI, WY, ID, VT, PR;    Foreign (OUS):  Canada, Argentina, Australia, Brazil, CHILE , Hong Kong, Japan, South Korea, Philippines, Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Romania, Spain, Sweden, Switzerland, Turkey, United Kingdom",
      "recall_number": "Z-0009-2019",
      "product_description": "ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AFX Limb Accessory Model #/REF: \t\t\t\t\t\t\t\t\t  I16-16/C55,\t\t  I16-16/C55F,\t\t  I16-16/C88,\t\t  I20-13/C70F,\t\t  I20-13/C88F,\t\t  I16-16/C55,\t\t  I16-16/C55F,\t\t  I16-16/C88,\t\t  I20-13/C70F,\t\t  I20-13/C88F;\t\t    AFX Stand Alone  I16-16/C55 SA,\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t  I16-16/C55F SA,\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t  I16-16/C88 SA,\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t  I20-13/C70F SA,\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t  I20-13/C88F SA,\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t  I20-20/C55 SA,\t\t\t\t\t  I20-20/C55F SA,\t\t\t\t\t  IS20-25/C55 SA,\t\t\t\t\t  IF20-25/C65 SA,\t\t\t\t\t  IS20-25/C65 SA",
      "product_quantity": "17789",
      "reason_for_recall": "Endologix is notifying physicians of patient tailored surveillance recommendations as well as general warnings/precautions for interventions to or through an existing AFX device.  This is a follow-up notification to the one that was sent out in December 2016.  The updates are related to the observation of Type III endoleaks.",
      "recall_initiation_date": "20180731",
      "center_classification_date": "20181003",
      "termination_date": "20240409",
      "report_date": "20181010",
      "code_info": "All lots distributed from 03/2011 to present.",
      "more_code_info": ""
    }
  ]
}