medical MODERATE Updated 2026-06-10

Covidien LLC recalls COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula

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Recalled 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.

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Hazard / Issue

Due to customer complaint regarding incorrect display box labeling.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Number: 6FEN UDI-DI code: 60884522007028 Lot Number: 25H0868JZX

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
View official government recall