{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "140321",
      "product_res_number": "Z-0113-2016",
      "event_date_initiated": "2015-09-11",
      "event_date_posted": "2015-10-08",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-03-13",
      "res_event_number": "72242",
      "product_code": "FEQ",
      "k_numbers": [
        "K100899"
      ],
      "product_description": "MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument channel port and the O FP-2 pump's tubing.",
      "code_info": "Models:  Part number K10016901 is a package of 10 pieces, Part number K10007072 is a package of 100 pieces\t\t\t  Part number K10016901: lot numbers 20115441, 20116536, Part number K10007072: lot numbers 20115441, 20116536",
      "firm_fei_number": "2429304",
      "recalling_firm": "Olympus Corporation of the Americas",
      "address_1": "PO Box 610 3500 Corporate Pkwy",
      "address_2": "PO Box 610",
      "city": "Center Valley",
      "state": "PA",
      "postal_code": "18034-8229",
      "additional_info_contact": "Customer Support\n484-896-5688",
      "reason_for_recall": "small puncture marks in a sterile package for an accessory to an Olympus device",
      "root_cause_description": "Process control",
      "action": "A letter of urgent device safety information, dated September 18, 2015, was sent to direct customers to inform them of the issue and instructions to cease use immediately. Customers were also asked to return the completed response form along with affected devices.",
      "product_quantity": "31060",
      "distribution_pattern": "US (nationwide) and Canada.",
      "openfda": {
        "k_number": [
          "K103696",
          "K132340",
          "K133747",
          "K163424",
          "K142155",
          "K100899",
          "K191559",
          "K220395",
          "K092429",
          "K153362",
          "K101146",
          "K120862",
          "K153588",
          "K161482",
          "K173650",
          "K112576",
          "K120123",
          "K100803",
          "K000948",
          "K182258",
          "K162152"
        ],
        "registration_number": [
          "1528319",
          "3008132398",
          "1000121056",
          "9610773",
          "1047843",
          "3010155648",
          "1651395",
          "3009106214",
          "3002807315",
          "3032507796",
          "3005726841",
          "2528981",
          "3010202439",
          "3004111573",
          "1643817",
          "9611174",
          "9681260",
          "3007007790",
          "3005099803",
          "3015219237",
          "3042872931",
          "1722746",
          "3006946348",
          "3004167615",
          "2020550",
          "3014926389",
          "3004530184",
          "3013348547",
          "3002808022",
          "2183446",
          "3008573567",
          "3007389669",
          "3013247477",
          "2518897",
          "3002807310",
          "9610617",
          "2246552",
          "1650907",
          "3017262662",
          "3003724334",
          "3008264255",
          "3014342096",
          "3017907746",
          "1721676",
          "3020712480",
          "1649518"
        ],
        "fei_number": [
          "1000122656",
          "1000121056",
          "3002681132",
          "1047843",
          "3001236277",
          "1000306216",
          "3002807091",
          "3010155648",
          "3002807798",
          "3009106214",
          "3002807315",
          "3032507796",
          "3005726841",
          "2528981",
          "3007475226",
          "1000080301",
          "3004111573",
          "1643817",
          "3007007790",
          "3005099803",
          "3015219237",
          "3042872931",
          "3003012447",
          "3006946348",
          "3004167615",
          "2020550",
          "3014926389",
          "3004530184",
          "3013348547",
          "3002808022",
          "2183446",
          "3008573567",
          "3007389669",
          "3013247477",
          "3002807310",
          "2246552",
          "3017262662",
          "3003724334",
          "3008264255",
          "3002806565",
          "1000162602",
          "3014342096",
          "3002808268",
          "3017907746",
          "1721676",
          "3020712480"
        ],
        "device_name": "Pump, Air, Non-Manual, For Endoscope",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2"
      }
    }
  ]
}