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Covidien LLC recalls COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are int
Recalled June 10, 2026 · FDA recall Z-2261-2026 · Covidien
Hazard
Due to customer complaint regarding incorrect display box labeling. · FDA Class II
Units
1,002
Sold at
Worldwide - U.S.: Nationwide distribution in the state of TX and the countries of France, French, Polynesia, Italy, Pakistan, Poland, Portugal, Spain, and Taiwan.
Description
Due to customer complaint regarding incorrect display box labeling.
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.
Manufacturer(s)
Covidien LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →