Recall Z-2653-2026 ยท BTO Tube, Tracheostomy (W/Wo Connector)
Covidien LLC
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 20884522
| Date | Jul 2, 2026 (initiated Apr 23, 2026) |
| Status | Open, Classified |
| Reason | 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 | 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 |
| Quantity | 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 c |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K843730 | SHILEY DISPOS. DECANNULATION PLUG W/SW/ Shiley, Inc., Oct 19, 1984 |