{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Boulder",
      "state": "CO",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "98819",
      "recalling_firm": "Covidien LLC",
      "address_1": "6135 Gunbarrel Ave",
      "address_2": "N/A",
      "postal_code": "80301-3214",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide distribution including in the states and territories of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and Virgin Islands. The countries of Albania, Andorra, Argentina, Australia, Austria, Belgium, Bhutan, Canada, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Finland, France, Georgia, Germany, Greece, Guadeloupe, Guyana, Hungary, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Latvia, Lithuania, Luxembourg, Martinique, Mexico, Netherlands, New Caledonia, New Zealand, North Macedonia, Norway, Oman, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Togo, Trinidad And Tobago, Turkey, Uganda, United Arab Emirates, Uruguay.",
      "recall_number": "Z-2653-2026",
      "product_description": "Covidien Shiley Disposable Decannulation Plug  REF  DDCP  UDI-DI code: 10884522004060    Product Codes that include the Covidien Shiley Disposable Decannulation Plug are:  Product Number /  UDI-DI code  4DCFN 10884522006576  4DCFS 10884522006583  4DFEN 10884522006606  6DCFN 10884522006613  6DCFS 10884522006620  6DFEN 10884522006644  8DCFN 10884522006651  8DCFS 40884522006690  8DFEN 10884522006675  10DCFN 20884522006535  10DCFS 10884522006545  10DFEN 10884522006569    The Shiley Disposable Decannulation Plug (DDCP) is a universal size and fits any size DCFS, DCFN, DFEN tracheostomy tube. The red DDCP snaplock connector is used to occlude the proximal end of the outer cannula on the Shiley Tracheostomy Tubes. Refer to Table 1 for model types. The DDCP blocks airflow through the tube and directs breathing through the mouth and nose. The Shiley Tracheostomy Tube and the accessory products are intended for use in providing tracheal access for airway management.",
      "product_quantity": "293,659 devices",
      "reason_for_recall": "Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.",
      "recall_initiation_date": "20260423",
      "center_classification_date": "20260702",
      "report_date": "20260708",
      "code_info": "Product Number: DDCP UDI-DI code: 10884522004060  The below product numbers and UDI-DI codes that DDCP are: 4DCFN / 10884522006576 4DCFS / 10884522006583 4DFEN / 10884522006606 6DCFN / 10884522006613 6DCFS / 10884522006620 6DFEN / 10884522006644 8DCFN / 10884522006651 8DCFS / 40884522006690 8DFEN / 10884522006675 10DCFN / 20884522006535 10DCFS / 10884522006545 10DFEN / 10884522006569"
    }
  ]
}