Z-2653-2026Class II

Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include...

Name: Z-2653-2026 Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include...
Creator: Covidien LLC
Published: 2026-04-23
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2026-04-23 / Open, Classified / root cause: labeling and UDI

FDA source

Covidien LLC began a recall of Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposable Decannulation Plug... on 2026-04-23. FDA classified it as Class II and gives the reason as "Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2653-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-23
Posted: 2026-07-02
Recalling firm: Medtronic, Inc.
Product: 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 code: BTO Tube, Tracheostomy (W/Wo Connector)
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
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.
Quantity in commerce: 293,659 devices
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2653-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2653-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-02

Product code BTO

K843730Class IIShiley Dispos. Decannulation Plug W/sw/Shiley, Inc. / cleared 1984-10-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)