COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN… — Class II medical device recall Z-2261-2026
Ongoing recall by Covidien LLC, reported 2026-06-10, distributed nationwide. Due to customer complaint regarding incorrect display box labeling.
| Recall number | Z-2261-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LLC, Boulder, CO, United States |
| Recall initiated | 2026-04-15 |
| Classified | 2026-05-29 |
| Reported by FDA | 2026-06-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | ES, FR, IT, PK, PL, PT, TW |
| Quantity | 1,002 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 60884522007028 |
| Lot numbers | 25H0868JZX |
| Model numbers | 6FEN |
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.
Reason for recall
Due to customer complaint regarding incorrect display box labeling.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2261-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.