FDA-Device2026-07-08Class IIMISBRANDING
Covidien Shiley Disposable Decannulation Plug recalled for incorrect DEHP labeling
What this means
The Shiley Disposable Decannulation Plug (DDCP), a red connector used on tracheostomy tubes to block airflow, carries labeling that incorrectly indicates it does not contain DEHP (a chemical compound). The product actually contains 30–35% DEHP. Users relying on the label may not be aware of DEHP exposure during use.
- Check your Shiley tracheostomy tube accessory kit for the DDCP (red snaplock connector) with product codes 4DCFN, 4DCFS, 4DFEN, 6DCFN, 6DCFS, 6DFEN, 8DCFN, 8DCFS, 8DFEN, 10DCFN, 10DCFS, or 10DFEN.
- Contact your healthcare provider or Covidien customer service for guidance on whether to continue use or obtain a replacement.
- Do not discard the product without instructions from your healthcare provider.
The agency's original wording
Hazard
Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.
Intended for
All ages
Illnesses reported
None reported
Sold states
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.
Affected count
293,659 devices
Manufactured in
6135 Gunbarrel Ave, N/A, Boulder, CO, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2653-2026Want us to check the next one for you?
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