FDA recall, , Moderate risk
COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula
The Shiley Tracheostomy Tube has incorrect display box labeling.
Summary by Recall Canary from the FDA notice
What happened
Covidien LLC, based in Boulder, Colorado, recalled its Covidien Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 due to a customer complaint regarding incorrect display box labeling. The devices are intended for use in providing tracheal access for airway management.
The recall began April 15, 2026, and was added to the FDA's Enforcement Report on May 29, 2026. Distribution included the state of TX and the countries of France, French Polynesia, Italy, Pakistan, Poland, Portugal, Spain, and Taiwan.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your tube affected?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices
- UDI-DI
- 60884522007028
- Lot code
- 25H0868JZX
Recall details
- Company began the recall
- Sold in
Worldwide - U.S.: Nationwide distribution in the state of Texas and the countries of France, French, Polynesia, Italy, Pakistan, Poland, Portugal, Spain, and Taiwan.
- Company
- Covidien LLCBoulder, Colorado
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98813
- Recall number
- Z-2261-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
