Reported Apr 2, 2025 · Ongoing

Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R

Covidien

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Covidien · 6135 Gunbarrel Ave · Boulder, CO · 80301-3214

Is this the product you have?

  • Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula
  • REF7CN80R
Lot codes and dates
  • UDI-DI/GTIN
    • A8845212054401
    • 20884521205441
    • 10884521205444
  • Lot202405258X
  • Expiration06/01/2029
Amount recalled
780

Why it was recalled

Stop using this product now

Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue injury, aspiration, respiratory tract infection, bronchospasm, a delay to treatment and/or death.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:36 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.