Covidien Shiley Disposable Decannulation Plug
Covidien recalls Shiley Disposable Decannulation Plug over incorrect non-DEHP labeling; product contains 30-35% DEHP.
Check your inventory for the affected Shiley Disposable Decannulation Plug (REF DDCP) and discontinue use immediately. Contact Covidien for instructions on returning the product and obtaining a replacement.
Recall at a glance
- Quantity recalled
- 293,659 devices
Why it was recalled
Covidien is recalling its Shiley Disposable Decannulation Plug (DDCP) because the product labeling incorrectly includes the symbol indicating non-DEHP, while the product actually contains 30 to 35% DEHP. The DDCP is a universal-size plug used to occlude the proximal end of the outer cannula on Shiley tracheostomy tubes. A range of sizes and pack formats is affected; the full list of product codes is available on the agency detail 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.
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
| Product | UDI-DI |
|---|---|
| Decann | 10884522004060, 10884522006576, 10884522006583, 10884522006606, 10884522006613, 10884522006620, 10884522006644, 10884522006651, 40884522006690, 10884522006675, 20884522006535, 10884522006545, 10884522006569 |
| Decannulation Plug (DDCP) | 10884522004060, 4DCFN, 10884522006576, 4DCFS, 10884522006583, 4DFEN, 10884522006606, 6DCFN, 10884522006613, 6DCFS, 10884522006620, 6DFEN, 10884522006644, 8DCFN, 10884522006651, 8DCFS, 40884522006690, 8DFEN, 10884522006675, 10DCFN, 20884522006535, 10DCFS, 10884522006545, 10DFEN, 10884522006569 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Labeling Error recalls
Other recent recalls from Covidien LLC
Editorial summary by Recall Canary · summary updated 2026-09-07 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification