Covidien LLC recalls COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN
- Recalling company
- Covidien LLC
- Product
- 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.
- Reason
- Due to customer complaint regarding incorrect display box labeling.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Apr 15, 2026
- Reported
- Jun 10, 2026
- Distribution
- Worldwide - U.S.: Nationwide distribution in the state of TX and the countries of France, French, Polynesia, Italy, Pakistan, Poland, Portugal, Spain, and Taiwan.
- Status
- Ongoing
- Quantity
- 1,002
- Lot / codes
- Product Number: 6FEN UDI-DI code: 60884522007028 Lot Number: 25H0868JZX
- Company location
- Boulder, CO
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2261-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2261-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.