{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "150221",
      "product_res_number": "Z-0380-2017",
      "event_date_initiated": "2016-10-06",
      "event_date_created": "2016-11-09",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-12-16",
      "res_event_number": "75409",
      "product_code": "NLH",
      "k_numbers": [
        "K012708",
        "K042074"
      ],
      "product_description": "Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters\n\nModel Numbers: \n401940, 402004\n\nUPC Code:\n00885825007409\n00885825007744\n\nDiagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a handpiece, a flexible shaft and a distal tip section containing diagnostic electrodes.\n\nReprocessed Diagnostic EP Catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.",
      "code_info": "Item Number Serial Number Manufacturing Date 401940 1902898 3/31/2015 401940 1908621 3/31/2015 402004 1902392 1/9/2015 402004 1902389 1/9/2015",
      "firm_fei_number": "3009350690",
      "recalling_firm": "Stryker Sustainability Solutions",
      "address_1": "1810 W Drake Dr",
      "city": "Tempe",
      "state": "AZ",
      "postal_code": "85283-4327",
      "additional_info_contact": "888-888-3433",
      "reason_for_recall": "The EP Catheters may be mislabeled for French size during reprocessing.",
      "root_cause_description": "Under Investigation by firm",
      "action": "The firm, Stryker, sent an \"URGENT MEDICAL DEVICE RECALL\" letter dated 10/6/2016 to its customers. The letter described the product, problem and actions to be taken.\n\nCustomers were instructed to discontinue use of the recalled product.  Other EP Catheters reprocessed by Stryker Sustainability Solutions should be considered as alternatives. To complete and Return the Recall Effectiveness Check Form, even if no affected product is found, to your local Stryker Sustainability Sales Representative or email to SSSPFA@stryker.com or mail to:\nStryker Sustainability Solutions\n1810 West Drake Drive\nTempe, AZ, 85283\nAttn: Jodie Rueckert\n\nIf you have any questions, contact Senior Director RA at 1(888)888-3433.",
      "product_quantity": "4 devices",
      "distribution_pattern": "U.S. distribution to the following; AZ, MN and MO.",
      "openfda": {
        "k_number": [
          "K252405",
          "K200205",
          "K160242",
          "K121158",
          "K180710",
          "K162251",
          "K190127",
          "K241224",
          "K012523",
          "K012708",
          "K170922",
          "K240972",
          "K090323",
          "K161464",
          "K221067",
          "K030114",
          "K052603",
          "K112232",
          "K161272",
          "K012688",
          "K023180",
          "K030279",
          "K030187",
          "K022316",
          "K161393",
          "K153153",
          "K051220",
          "K112292",
          "K241156",
          "K050763",
          "K101789",
          "K171788",
          "K160421",
          "K171503",
          "K030026",
          "K242225",
          "K221854",
          "K160303",
          "K203655",
          "K030109",
          "K181618",
          "K233825",
          "K040751",
          "K250772",
          "K051043",
          "K240826",
          "K193263",
          "K153006",
          "K061045",
          "K150357",
          "K160496",
          "K052414",
          "K182488",
          "K181056",
          "K042074",
          "K211276",
          "K181458",
          "K043513",
          "K161827",
          "K012687",
          "K043393",
          "K043392",
          "K151617",
          "K081329",
          "K082023",
          "K191170",
          "K092158",
          "K181897",
          "K012678",
          "K100254"
        ],
        "registration_number": [
          "2090040",
          "3011024991",
          "3009888344",
          "3009350690",
          "3032391",
          "3011276773",
          "1319639",
          "2183744",
          "2011171",
          "3011610434",
          "2032112"
        ],
        "fei_number": [
          "3011024991",
          "3009888344",
          "3002615969",
          "3009350690",
          "1000138054",
          "3003076831",
          "3002299608",
          "3011276773",
          "2183744",
          "2011171",
          "3011610434"
        ],
        "device_name": "Catheter, Recording, Electrode, Reprocessed",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1220",
        "device_class": "2"
      }
    }
  ]
}