{
  "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": "168248",
      "product_res_number": "Z-0467-2019",
      "event_date_initiated": "2018-08-23",
      "event_date_created": "2018-11-14",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-02-04",
      "res_event_number": "81321",
      "product_code": "NLH",
      "k_numbers": [
        "K112292"
      ],
      "product_description": "Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.",
      "code_info": "Item Number  Serial Number D134903         2519054 D134903         2534027  Note:  Item # D134909 is not approved for reprocessing by Stryker s Sustainability Solutions Division. Therefore, SSS does not create or possess D134909 labeling. SSS did not receive labeling from the manufacturer.",
      "firm_fei_number": "3009350690",
      "recalling_firm": "Stryker Sustainability Solutions",
      "address_1": "1810 W Drake Dr",
      "city": "Tempe",
      "state": "AZ",
      "postal_code": "85283-4327",
      "reason_for_recall": "Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for reprocessing.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On 10/30/2018 an Urgent Medical Device Recall notice was hand-delivered by a sales representative to the customer. The customer was notified that the affected devices had already been returned via the normal collections process. If affected devices were forwarded to additional facilities, the customer was asked to communicate this recall to them and to provide them with the recall effectiveness check form. Customers were asked to complete and return the recall effectiveness check form.",
      "product_quantity": "2",
      "distribution_pattern": "US: KS\n\nOUS: None",
      "openfda": {
        "k_number": [
          "K051043",
          "K012523",
          "K181618",
          "K052603",
          "K240826",
          "K161393",
          "K030026",
          "K043392",
          "K082023",
          "K043513",
          "K042074",
          "K200205",
          "K180710",
          "K153153",
          "K190127",
          "K221854",
          "K052414",
          "K241156",
          "K160496",
          "K240972",
          "K030109",
          "K181056",
          "K023180",
          "K160303",
          "K162251",
          "K161272",
          "K160421",
          "K161827",
          "K051220",
          "K193263",
          "K161464",
          "K241224",
          "K151617",
          "K030279",
          "K030187",
          "K121158",
          "K100254",
          "K250772",
          "K012688",
          "K252405",
          "K221067",
          "K101789",
          "K081329",
          "K160242",
          "K112232",
          "K012687",
          "K090323",
          "K022316",
          "K043393",
          "K150357",
          "K211276",
          "K233825",
          "K040751",
          "K012678",
          "K181897",
          "K061045",
          "K191170",
          "K170922",
          "K171503",
          "K242225",
          "K153006",
          "K030114",
          "K171788",
          "K203655",
          "K050763",
          "K112292",
          "K182488",
          "K092158",
          "K012708",
          "K181458"
        ],
        "registration_number": [
          "2090040",
          "3009888344",
          "2032112",
          "3011276773",
          "2183744",
          "2011171",
          "1319639",
          "3009350690",
          "3011024991",
          "3032391",
          "3011610434"
        ],
        "fei_number": [
          "3009888344",
          "3011276773",
          "1000138054",
          "2183744",
          "2011171",
          "3009350690",
          "3011024991",
          "3003076831",
          "3002615969",
          "3002299608",
          "3011610434"
        ],
        "device_name": "Catheter, Recording, Electrode, Reprocessed",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1220",
        "device_class": "2"
      }
    }
  ]
}