COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code:... recall (Covidien LLC)
Medical deviceClass IIOngoing
Summary: Covidien LLC is recalling COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management. Shiley Tracheostomy Tubes are double cannula tracheostomy tubes with reusable inner cannulae (LPC, FEN, CFS, CFN. Reason: Due to customer complaint regarding incorrect display box labeling.
What is being recalled
COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management. Shiley Tracheostomy Tubes are double cannula tracheostomy tubes with reusable inner cannulae (LPC, FEN, CFS, CFN, LGT) and twist-lock connectors. These Shiley Tracheostomy Tubes have a radiopaque, biocompatible outer cannula constructed of polyvinyl chloride.
Why
Due to customer complaint regarding incorrect display box labeling.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide - U.S.: Nationwide distribution in the state of TX and the countries of France, French, Polynesia, Italy, Pakistan, Poland, Portugal, Spain, and Taiwan. (states named: Texas)
How to tell if yours is affected
Product Number: 6FEN UDI-DI code: 60884522007028 Lot Number: 25H0868JZX
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2261-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 15, 2026 |
| Reported | June 10, 2026 |
| Company | Covidien LLC |
| Company location | Boulder, CO, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 1,002 |
More recalls from Covidien LLC · all medical device recalls · recalls from April 2026