Covidien Shiley Tracheostomy Tube
Covidien is recalling Shiley Tracheostomy Tubes due to incorrect display box labeling.
Check the product packaging and device labeling to ensure the contents match the box description. Contact Covidien or your medical supplier if you have concerns about the device identification.
Why it was recalled
Covidien is recalling specific Shiley Tracheostomy Tubes with inner cannulae due to incorrect labeling on the product display box. This error may lead to confusion regarding the specific device specifications contained within the packaging.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
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.
- UPC
- 60884522007028
- Recall #
- Z-2261-2026
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Covidien LLC
Editorial summary by Recall Canary · last updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification