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

FDA device recall Z-2653-2026 · posted 2026-07-02 · Open, Classified

Recall details

Recalling firm

Covidien LLC

Reason for recall

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

Action taken

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 this notice in all care environments where the affected products are used to maintain awareness to this labeling issue. -Share this notice with all relevant personnel within their organization, and with any organization to which the affected product has been transferred or distributed. -Complete and return the enclosed Customer Confirmation Form to rs.gmbmitgfca@medtronic.comeven if you do not have unused inventory. Any questions regarding this communication, contact Medtronic Representative or Customer Service at 800-962-9888.

Root cause

Labeling Change Control

Status

Open, Classified

Product code

BTO

Quantity affected

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,

Date initiated

2026-04-23

Date posted

2026-07-02

Location

Boulder, CO

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