FDA recall notice
Medtronic Removes Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable…
FDA Recall Confirmed · Tube tracheostomy and tube cuff · posted Jun 5, 2025
Key facts
| Notice | Medtronic Removes Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula Due to Risk for Disconnection of the Flange from the Device Cannula |
|---|---|
| Device type | Tube tracheostomy and tube cuff |
| Status | Recall Confirmed |
| Posted | Jun 5, 2025 |
| Notice on fda.gov | fda.gov |
At a glance
- Confirmed Recall confirmed
- Yes Currently listed by the FDA
- None Recall events referenced
- 1–9 UDI device identifiers named
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recall notices and early alerts
The FDA's Medical Device Recalls and Early Alerts list covers the most serious device recalls, plus early alerts about potentially high-risk device issues while the FDA is still collecting information. A notice is updated as the recall is confirmed or changes.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls and Early Alerts · Source date: