FDAHealthApril 15, 2026
Covidien LLC — 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.
⚠️ Due to customer complaint regarding incorrect display box labeling.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 15, 2026
Worldwide - U.S.: Nationwide distribution in the state of TX and the countries of France, French, Polynesia, Italy, Pakistan, Poland, Portugal, Spain, and Taiwan.
What's affected?
- 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.
- Brand
- Covidien LLC
- Lot code
- 25H0868JZX
Additional details
Product Number: 6FEN UDI-DI code: 60884522007028 Lot Number: 25H0868JZX
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1,002.
Get Health recall alerts
Delivered to your inbox. Free. No account required.