{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "95737",
      "product_res_number": "Z-0628-2011",
      "event_date_initiated": "2010-02-19",
      "event_date_posted": "2010-12-16",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-07-30",
      "res_event_number": "57281",
      "product_code": "KOG",
      "k_numbers": [
        "K832458"
      ],
      "product_description": "ASP Automatic Endoscope Reprocessor (AER), Product Code: 20300 & 20301\nThe AER is a machine designed to automatically wash and high-level disinfect flexible, submersible fiberoptic or video endoscopes.",
      "code_info": "Product Code: 20300 & 20301",
      "firm_fei_number": "3003662624",
      "recalling_firm": "Advanced Sterilization Products",
      "address_1": "33 Technology Drive",
      "city": "Irvine",
      "state": "CA",
      "postal_code": "92618",
      "additional_info_contact": "Ruben Lawson\n949-789-8545",
      "reason_for_recall": "The recall was initiated because Advanced Sterilization Products (ASP) received three customer\nreports of elevated temperature of the high-level disinfectant solution used in the ASP AER as a result of a\npossible temperature monitoring system malfunction. This recall communication advised consignees that if high-level\ndisinfectants are exposed to elevated temperatures, fumes may occur and resul",
      "root_cause_description": "Pending",
      "action": "Advanced Sterilization Products sent an URGENT:  PRODUCT CORRECTION letter dated February 19, 2010, to all customers.  The letter identified the product, the problem, and the action to be taken by the customer.  The recall communication was initiated with ASP forwarding a \"Urgent: Product Correction\" letter with attached customer fax-back response form to the affected customers.   \nCustomers were also instructed to complete and sign the enclosed customer fax-back response form indicating that they have disconnected the heater on the ASP AER according to the instructions provided and fax the form to 1-888-345-1435.\n\nIf customers have any questions or need assistance, they were instructed to call ASP Professional Services at 888-783-7723, option 3 then option 1.",
      "product_quantity": "1,881 units (1514 in US)",
      "distribution_pattern": "Worldwide Distribution -- United States, Argentina Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador,\nHungary, Mexico, Panama, Guatemala, Honduras, Poland, Puerto Rico, Virgin Islands, Singapore, Taiwan,\nVenezuela, Croatia, and Bulgaria.",
      "openfda": {}
    }
  ]
}