{
  "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": [
    {
      "status": "Terminated",
      "city": "Blue Ash",
      "state": "OH",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "71551",
      "recalling_firm": "Ethicon Endo-Surgery Inc",
      "address_1": "4545 Creek Rd",
      "address_2": "N/A",
      "postal_code": "45242-2803",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution including OH, RI, TX & WA.",
      "recall_number": "Z-2374-2015",
      "product_description": "SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01.     An integrated physiological monitoring and drug delivery system intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures.    Intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures.",
      "product_quantity": "14 units",
      "reason_for_recall": "Ethicon has found that disinfecting methods not specified in the Instructions For Use (IFU) have led to the degradation of the plastic material of the SEDASYS System Control Unit.",
      "recall_initiation_date": "20150513",
      "center_classification_date": "20150826",
      "termination_date": "20160502",
      "report_date": "20150902",
      "code_info": "Model #SEDPRU01"
    }
  ]
}