Fresh Recalls

Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: recall status

Notice names this product. Covidien’s Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code is named in FDA Class II recall Z-2653-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP. Identifying details: 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. Units affected: 293,659 devices. Status: Ongoing.

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This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code
Company / brand
Covidien
Lot / serial / date codes
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
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.
Agency product description and boundaries

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.

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

Brand
Covidien

Recalls naming this model

FDA Class II · Medical device · July 8, 2026

Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code recall — Covidien LLC

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

Company / brand: Covidien

Affected product: Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code

Official ID Z-2653-2026 · Official record ↗

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Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.