{"url_path":"/fda/device/recalls/Z-2261-2026","section_key":"summary","section_title":"DEVICE Recall: Covidien LLC — 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 ha…","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-04-15","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2261-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Covidien LLC"},"word_count":134,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2261-2026\n\n**Recalling firm:** Covidien LLC\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-15\n**Report date:** 2026-06-10\n\n## Product\nCOVIDIEN 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.\n\n## Reason\nDue to customer complaint regarding incorrect display box labeling.\n\n## Affected lots\nProduct Number: 6FEN UDI-DI code: 60884522007028 Lot Number: 25H0868JZX\n\n## Distribution\nWorldwide - U.S.: Nationwide distribution in the state of TX and the countries of France, French, Polynesia, Italy, Pakistan, Poland, Portugal, Spain, and Taiwan."}