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.

Class II

Recalling firm: Covidien LLC
Reason for recall: Due to customer complaint regarding incorrect display box labeling.
Affected products (lot / model / serial): Product Number: 6FEN UDI-DI code: 60884522007028 Lot Number: 25H0868JZX
Units affected: 1,002
Distribution pattern: Worldwide - U.S.: Nationwide distribution in the state of TX and the countries of France, French, Polynesia, Italy, Pakistan, Poland, Portugal, Spain, and Taiwan.
Firm location: Boulder, CO, United States
Recall type: Voluntary: Firm initiated
How the firm notified customers: Letter
Product type: Devices
Status: Ongoing
Recall number: Z-2261-2026
Recall initiated: April 15, 2026
FDA classification date: May 29, 2026
FDA report date: June 10, 2026
FDA event ID: 98813
Last updated on HTM Vibe: July 23, 2026