FDA Device recall Z-2261-2026
COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in provid…
- FDA Device
- Class II
- ongoing
- Published 2026-06-10
On 2026-06-10 the FDA classified a Class II recall of COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in provid… by Covidien, citing due to customer complaint regarding incorrect display box labeling.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2261-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-15 |
| Published | 2026-06-10 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Covidien |
| Distribution | US |
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
Due to customer complaint regarding incorrect display box labeling.
Identifiers
| code_info | Product Number: 6FEN UDI-DI code: 60884522007028 Lot Number: 25H0868JZX |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2261-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.