{
  "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": "Boulder",
      "state": "CO",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "71197",
      "recalling_firm": "Covidien LP (formerly Nellcor Puritan Bennett Inc.)",
      "address_1": "6135 Gunbarrel Ave",
      "address_2": "N/A",
      "postal_code": "80301-3214",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution.  US nationwide, Canada, Australia, Belgium, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, and Uruguay.",
      "recall_number": "Z-1950-2015",
      "product_description": "Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless.  Model Numbers: 2.5NEF,3.0NEF,3.5NEF,4.0NEF,4.5NEF,2.5PEF,3.0PEF,3.5PEF,4.0PEF,4.5PEF,5.0PEF,5.5PEF,5.0PELF,5.5PELF,6.0PELF,6.5PELF,2.5NCF,3.0NCF,3.5NCF,4.0NCF,4.5NCF,2.5PCF,3.0PCF,3.5PCF,4.0PCF,4.5PCF,5.0PCF,5.5PCF,5.0PLCF,5.5PLCF,6.0PLCF,6.5PLCF,3.0NEF-P,3.5NEF-P,4.0NEF-P,4.5NEF-P,3.0PEF-P,3.5PEF-P,4.0PEF-P,4.5PEF-P,5.0PEF-P,5.5PEF-P,",
      "product_quantity": "69,461 units total",
      "reason_for_recall": "Reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the affected products experienced discomfort and in some cases, breathing difficulties, corresponding to a negative effect on oxygen levels.",
      "recall_initiation_date": "20150508",
      "center_classification_date": "20150709",
      "termination_date": "20170412",
      "report_date": "20150715",
      "code_info": "All products manufactured since 2/2012.  Including All lot numbers beginning with 12, 13 and 14."
    }
  ]
}