Reported Jul 8, 2026 · Ongoing

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

Covidien LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Covidien LLC · 6135 Gunbarrel Ave · Boulder, CO · 80301-3214

Is this the product you have?

  • Covidien Shiley Disposable
  • Decannulation Plug REF DDCP UDI-DI code10884522004060 Product Codes that include the Covidien Shiley
  • Disposable Decannulation Plug areProduct 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
Lot codes and dates
  • Product NumberDDCP
  • UDI-DI code10884522004060 The below product
  • numbers and UDI-DI codes that DDCP are4DCFN / 10884522006576 4DCFS / 10884522006583 4DFEN / 10884522006606 6DCFN / 10884522006613 6DCFS / 10884522006620 6DFEN / 10884522006644 8DCFN / 10884522006651 8DCFS / 40884522006690 8DFEN / 10884522006675 10DCFN / 20884522006535 10DCFS / 10884522006545 10DFEN / 10884522006569
Amount recalled
293,659 devices

Where it was sold

Why it was recalled

Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 2:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.