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Open, Classified

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.

FDA Recall Z-2653-2026 · Posted 2026-07-02

Recalling FirmCovidien LLC
Recall StatusOpen, Classified
Product CodeBTO
Date Initiated2026-04-23
Product Quantity293,659 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.

Firm Action

On 04/23/2026, an "Urgent Medical Device Correction" letter was mail/email to customers informing them that the labeling for all lots of Covidien Shiley" disposable decannulation plugs incorrectly includes the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate). The seal of this product includes 30 to 35% DEHP. Customers are instructed to: -No additional action is required by clinicians for the care or follow-up of patients who are using or have used Covidien Shiley" disposable decannulation plugs. -Customers can continue to use the Covidien Shiley" disposable decannulation plugs. -Post this notice in all care environments where the affected products are used to maintain awareness to this labeling issue. -Share this notice with all relevant personnel within their organization, and with any organization to which the affected product has been transferred or distributed. -Complete and return the enclosed Customer Confirmation Form to [email protected] if you do not have unused inventory. Any questions regarding this communication, contact Medtronic Representative or Customer Service at 800-962-9888.

Root Cause

Labeling Change Control

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K843730SHILEY DISPOS. DECANNULATION PLUG W/SW/Shiley, Inc. · 1984-10-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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