Z-2261-2026 Class II Ongoing
FDA device recall Z-2261-2026 was initiated by Covidien LLC on April 15, 2026 and is designated Class II. Reason for recall: Due to customer complaint regarding incorrect display box labeling. The recall status is ongoing. Affected quantity: 1,002.
Recall Details
- Product Type
- Devices
- Report Date
- June 10, 2026
- Initiation Date
- April 15, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,002
Product Description
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.
Reason for Recall
Due to customer complaint regarding incorrect display box labeling.
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.
Code Information
Product Number: 6FEN UDI-DI code: 60884522007028 Lot Number: 25H0868JZX