Covidien Shiley Disposable Decannulation Plug
Covidien is recalling 12+ models of Shiley Disposable Decannulation Plugs due to incorrect labeling regarding DEHP content.
Check your product packaging and labeling against the list of affected models provided on the FDA recall website. If you possess an affected device, discontinue use and contact your healthcare provider or Covidien for further instructions.
Why it was recalled
Covidien is recalling 12+ models of the Shiley Disposable Decannulation Plug because the product labeling incorrectly indicates the device is non-DEHP, when it actually contains 30% to 35% DEHP. The full list of affected product numbers and UDI-DI codes is available on the FDA recall page.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | UPC | Recall # |
|---|---|---|
| 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 Decann | 10884522004060, 10884522006576, 10884522006583, 10884522006606, 10884522006613, 10884522006620, 10884522006644, 10884522006651, 40884522006690, 10884522006675, 20884522006535, 10884522006545, 10884522006569 | Z-2653-2026 |
| 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. | – | – |
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Covidien LLC
Editorial summary by Recall Canary · last updated 2026-07-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification