{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "161728",
      "product_res_number": "Z-0643-2018",
      "event_date_initiated": "2018-02-13",
      "event_date_posted": "2018-02-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-10-09",
      "res_event_number": "79237",
      "product_code": "FDT",
      "k_numbers": [
        "K092710",
        "K161222"
      ],
      "product_description": "Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420)\n\n\nThese 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.",
      "code_info": "All Serial Numbers",
      "firm_fei_number": "1000080301",
      "recalling_firm": "Pentax of America Inc",
      "address_1": "3 Paragon Dr",
      "city": "Montvale",
      "state": "NJ",
      "postal_code": "07645-1782",
      "additional_info_contact": "Charlie Toms\n800-451-5880 Ext. 2064",
      "reason_for_recall": "The duodenoscopes are being recalled in order to replace the forceps elevator mechanism, the O-rings, and the distal end covering to be consistent with the updated design as well as provide an updated periodic inspection as part of the Operation Manual in order to mitigate the potential risk of infection in flexible endoscopy.",
      "root_cause_description": "Device Design",
      "action": "Pentax Medical sent an Urgent Medical Device Correction/Removal letter dated February 7, 2018, to the United States Customers. \n\nThe consignee letter includes a customer response form and a revised operator manual with the added recommended periodic maintenance. The letter requests the return of the form which includes an accounting of the devices (by serial number) owned by the facility. The firm is to contact the consignee to arrange return of the affected units and to provide loaner devices as needed. For further questions, please call 1 (800) 431-5880 ext. 2064.",
      "product_quantity": "559",
      "distribution_pattern": "USA (nationwide) Distribution to the states of including Puerto Rico : AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, WV and  WY, and  the District of Columbia.",
      "openfda": {
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          "K203028",
          "K961568",
          "K080403",
          "K201098",
          "K250701",
          "K092710",
          "K163614",
          "K193182",
          "K253646",
          "K220587",
          "K110833",
          "K152257",
          "K942338",
          "K143153",
          "K161222",
          "K962212",
          "K980465",
          "K024033",
          "K233886",
          "K233942",
          "K042076",
          "K193202",
          "K251861",
          "K963056",
          "K210710",
          "K202661",
          "K192245",
          "K191747",
          "K251867",
          "K181745",
          "K192280",
          "K182051",
          "K181522",
          "K832006"
        ],
        "device_name": "Duodenoscope And Accessories, Flexible/Rigid",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2",
        "registration_number": [
          "3010772972",
          "3042225166",
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}