{
  "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": "123534",
      "product_res_number": "Z-0402-2014",
      "event_date_initiated": "2013-11-11",
      "event_date_posted": "2013-11-26",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-01-22",
      "res_event_number": "66815",
      "product_code": "MLR",
      "k_numbers": [
        "K071385"
      ],
      "product_description": "STERRAD 100NX, Product Code: 10104\n\nThe STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.",
      "code_info": "Please refer to consignee list",
      "firm_fei_number": "3003662624",
      "recalling_firm": "Advanced Sterilization Products",
      "address_1": "33 Technology Dr",
      "city": "Irvine",
      "state": "CA",
      "postal_code": "92618-2346",
      "additional_info_contact": "949-453-6400",
      "reason_for_recall": "Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyurethane material in the suction channel location that is not listed in the current claims for interior channels (lumens) for processing in STERRAD systems.",
      "root_cause_description": "Labeling design",
      "action": "Advanced Sterilization Products sent an Urgent Medical Device Field Safety Notificaiton letter on November 11, 2013, to all affected customers.  The letter informed customers of the problems identified and the actions to be taken.  \nCustomers were instructed to provide the notice to anyone in their facility that needs to be informed and post this notice where appropriate. Customers were instructed to contact ASP at 1-888-783-7723 for any suspected problems.  \n\nASP is collaborating with KARL STORZ Endoskope to determine the sterilization impact of the suction port lumen material.  Customers are instructed to contact KARL STORZ Endoskope Technical Support at (800)421-0837, ext 5350 for alternative reprocessing instructions.\nFor questions regarding this recall call 949-453-6400.",
      "product_quantity": "Total 4,381 units",
      "distribution_pattern": "Nationwide Distribution",
      "openfda": {
        "k_number": [
          "K071385",
          "K231893",
          "K102330",
          "K042116",
          "K160818",
          "K172319",
          "K111810",
          "K233762",
          "K250802",
          "K212174",
          "K223476",
          "K102394",
          "K190103",
          "K160903",
          "K131120",
          "K162413",
          "K142454",
          "K162007",
          "K220345",
          "K222093",
          "K160433",
          "K172754",
          "K092622",
          "K140498",
          "K234082",
          "K231169",
          "K943654",
          "K120632",
          "K083097",
          "K112760",
          "K030429",
          "K252843",
          "K140464",
          "K981625",
          "K190917",
          "K220404",
          "K924380",
          "K991999",
          "K233065",
          "K111377",
          "K212200",
          "K223015",
          "K112813",
          "K190005",
          "K182568",
          "K062297",
          "K151725"
        ],
        "registration_number": [
          "3016075971",
          "3001124136",
          "3013934196",
          "3012494290",
          "3014848734",
          "9680353",
          "3000268902",
          "3035366890",
          "3030733800",
          "3015542154",
          "3005646850",
          "3003950207",
          "3015392401",
          "2084725",
          "3014302784",
          "1822565",
          "3013557562",
          "3005899764",
          "3013176080",
          "3012892649",
          "3011683674",
          "3043237009",
          "1527821",
          "3014272734",
          "3015207155"
        ],
        "fei_number": [
          "3016075971",
          "3001124136",
          "3003662624",
          "3013934196",
          "3012494290",
          "3014848734",
          "3000268902",
          "3035366890",
          "3030733800",
          "3015542154",
          "3005646850",
          "3003950207",
          "3004097451",
          "3015392401",
          "3014302784",
          "3013557562",
          "3005899764",
          "3013176080",
          "3012892649",
          "3011683674",
          "3043237009",
          "1527821",
          "3014272734",
          "3015207155",
          "1000220733"
        ],
        "device_name": "Sterilizer, Chemical",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.6860",
        "device_class": "2"
      }
    }
  ]
}