{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Tempe",
      "address_1": "1810 W Drake Dr",
      "reason_for_recall": "The EP Catheters may be mislabeled for French size during reprocessing.",
      "address_2": "",
      "product_quantity": "4 devices",
      "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",
      "center_classification_date": "20161109",
      "distribution_pattern": "U.S. distribution to the following; AZ, MN and MO.",
      "state": "AZ",
      "product_description": "Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters    Model Numbers:   401940, 402004    UPC Code:  00885825007409  00885825007744    Diagnostic 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.    Reprocessed Diagnostic EP Catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.",
      "report_date": "20161116",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Stryker Sustainability Solutions",
      "recall_number": "Z-0380-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "75409",
      "termination_date": "20161216",
      "more_code_info": "",
      "recall_initiation_date": "20161006",
      "postal_code": "85283-4327",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}