Covidien recalls disposable decannulation plugs with incorrect DEHP labeling that may include harmful phthalates. Affected products have specific UDI-DI codes and product numbers for tracheostomy tube access.
Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.
Covidien is recalling disposable decannulation plugs that incorrectly label themselves as non-DEHP (a harmful phthalate) when they actually contain 30-35% DEHP. This could pose health risks for patients using tracheostomy tubes.
The product labels incorrectly state it contains no DEHP (a phthalate chemical), but the actual product contains 30-35% DEHP. DEHP is a known endocrine disruptor that can cause health issues with long-term exposure, especially in medical devices.
Healthcare providers and patients using tracheostomy tubes who have the specific product codes listed in the recall. Those with the DDCP plug for tracheostomy tube access are most at risk.
Check for product numbers like 4DCFN, 6DCFN, or 10DCFN with UDI-DI codes starting with 1088452200. The product includes a red snaplock connector for tracheostomy tubes.
Identify the product number and UDI-DI code on the plug to confirm if it matches the recalled items listed in the notice.
The product labels incorrectly state it contains no DEHP, but it actually contains 30-35% DEHP, a harmful phthalate chemical.
The product contains DEHP (a known endocrine disruptor) but is labeled as non-DEHP, which could pose health risks with long-term use.
Check for product numbers like 4DCFN, 6DCFN, or 10DCFN with UDI-DI codes starting with 1088452200.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-2653-2026 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-2653-2026 from Covidien. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
