Class II U.S. Food and Drug Administration

Covidien Shiley Disposable Decannulation Plug REF Ddcp Udi-Di code recall: Due to product labeling incorrectly including the symbol indicating non-DEHP

Recall published 4 months ago

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

The hazard: Lead or heavy metal content

The recall is about heavy metal content exceeding what U.S. law allows in a product children handle.

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

Why it matters: The product exceeds the federal limit on lead or another heavy metal. Lead harms the developing brain, and the damage builds quietly from small repeated exposures rather than arriving as a single dramatic poisoning.

Symptoms and when to call a doctor

The CDC states there is no known safe level of lead in a child’s blood, and that most children with elevated levels show no symptoms at all. That is why a blood lead test, not a symptom check, is the way to find out. Ask your paediatrician about testing if a child has handled, mouthed or worn the product regularly. Where symptoms do appear they are non-specific — irritability, poor appetite, stomach pain, tiredness, constipation or a drop in attention and learning.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-2653-2026
Published
July 8, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Covidien LLC
Product type
Medical devices
Units affected
293,659 devices
Distribution
Nationwide
Made in
United States
Lot / code info
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
UPC codes
10884522004060, 10884522006576, 10884522006583, 10884522006606, 10884522006613, 10884522006620, 10884522006644, 10884522006651, 40884522006690, 10884522006675, 20884522006535, 10884522006545, 10884522006569

Products covered by this recall

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.

Check your product

The notice names 13 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10884522004060
  • 10884522006576
  • 10884522006583
  • 10884522006606
  • 10884522006613
  • 10884522006620
  • 10884522006644
  • 10884522006651
  • 40884522006690
  • 10884522006675
  • 20884522006535
  • 10884522006545
  • 10884522006569

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Lead

Covidien LLC — The recall is about heavy metal content exceeding what U.S. law allows in a product children handle.

  1. Take the product away from children and stop using it — do not keep it for decoration where a child can reach it.
  2. Ask your paediatrician whether a blood lead test is warranted, especially for a child under six or anyone pregnant.
  3. Do not sand, scrape, burn or break the item up; that turns a contained hazard into dust you can breathe.
  4. Follow the remedy on this page — lead recalls almost always carry a full refund.

If the claim stalls

Most recall claims are paid without argument. The ones that stall usually stall for a reason you can fix.

  • Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.
  • Send the photos they asked for in the format they asked for. A missing date code is the single commonest reason a claim sits unprocessed.
  • Give it ten working days, then chase in writing and quote your claim reference.
  • If the company is unresponsive or has stopped trading, report it to the CPSC at SaferProducts.gov, and try the retailer in parallel.

Company contact: Covidien LLC — 6135 Gunbarrel Ave, Boulder, CO, 80301-3214

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Covidien LLC medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10884522004060, 10884522006576, 10884522006583. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Take the product away from children and stop using it — do not keep it for decoration where a child can reach it.

Can I get my money back?

Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.

Where was the recalled product sold?

It was distributed nationwide.

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