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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien Shiley" Disposable Decannulation Plug

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 Class 2 Device Recall Covidien Shiley" Disposable Decannulation Plugsee related information
Date Initiated by FirmApril 23, 2026
Date PostedJuly 02, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2653-2026
Recall Event ID 98819
510(K)NumberK843730 
Product Classification Tube, tracheostomy (w/wo connector) - Product Code BTO
ProductCovidien 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.
Code Information 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
FEI Number 2936999
Recalling Firm/
Manufacturer		 Covidien LLC
6135 Gunbarrel Ave
Boulder CO 80301-3214
For Additional Information ContactTechnical and Clinical Support
800-255-6774 Ext. 6
Manufacturer 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.
FDA Determined
Cause 2		Labeling Change Control
ActionOn 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 rs.gmbmitgfca@medtronic.comeven if you do not have unused inventory. Any questions regarding this communication, contact Medtronic Representative or Customer Service at 800-962-9888.
Quantity in Commerce293,659 devices
DistributionU.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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = BTO
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