{
  "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": [
    {
      "country": "United States",
      "city": "Montvale",
      "address_1": "3 Paragon Dr",
      "reason_for_recall": "Pentax initiated a field correction/safety alert  for  two (2) models of the Video Duodenoscope to determine how soiling may have occurred on the surface of the suction cylinder and under the distal cap during testing.",
      "address_2": "",
      "product_quantity": "2,015 (US - 519 (ED-3490TK) and 5 (ED-3270K); OUS - 1,491)",
      "code_info": "Model Numbers: Ed-3490TK and ED-3270K",
      "center_classification_date": "20170710",
      "distribution_pattern": "Worldwide Distribution-US (Nationwide) including states of: AL, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, PR, TN, TX, UT, VA, WA, WI, WV, WY;. and country of: CANADA.",
      "state": "NJ",
      "product_description": "Video Duodenoscope    These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic and cystic ducts.",
      "report_date": "20170719",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Pentax of America Inc",
      "recall_number": "Z-2713-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "77308",
      "termination_date": "20180308",
      "more_code_info": "",
      "recall_initiation_date": "20170117",
      "postal_code": "07645-1782",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}