Covidien Shiley Disposable Decannulation Plug Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Covidien LLC is recalling 293,659 Shiley Disposable Decannulation Plugs due to incorrect labeling regarding DEHP content.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 7, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Covidien LLC initiated a voluntary recall of the Shiley Disposable Decannulation Plug because product labeling incorrectly includes the symbol indicating non-DEHP, while the product includes 30 to 35% DEHP.
Which Products Are Affected
The recall affects the Covidien Shiley Disposable Decannulation Plug (REF DDCP, UDI-DI code: 10884522004060). It is a universal size that fits DCFS, DCFN, and DFEN tracheostomy tubes. Affected product numbers and UDI-DI codes include: 4DCFN (10884522006576), 4DCFS (10884522006583), 4DFEN (10884522006606), 6DCFN (10884522006613), 6DCFS (10884522006620), 6DFEN (10884522006644), 8DCFN (10884522006651), 8DCFS (40884522006690), 8DFEN (10884522006675), 10DCFN (20884522006535), 10DCFS (10884522006545), and 10DFEN (10884522006569). A total of 293,659 devices are affected. Distribution was nationwide in the U.S. including 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, plus numerous international countries.
What You Should Do
The recall notice does not specify consumer actions.
Why This Matters
The mislabeling involves the presence of DEHP in a device used for airway management in tracheostomy patients.
Source
FDA recall number Z-2653-2026, Class II, event ID 98819.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,415 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.