FDA recall notice
Endoscope Instrument Recall: Olympus Removes Single Use Guide Sheath Kits Due to Risk for…
FDA Recall Confirmed · Sheath Kit · posted Feb 28, 2025
Key facts
| Notice | Endoscope Instrument Recall: Olympus Removes Single Use Guide Sheath Kits Due to Risk for Radiopaque Guide Sheath Tip Detaching During Procedures |
|---|---|
| Device type | Sheath Kit |
| Status | Recall Confirmed |
| Posted | Feb 28, 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: