Official recall notice
FDA DeviceClass IINotable
FDA Recall: Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological appl
- Recall date
- 2026-03-04
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Complaints of the ceramic tip of the resection sheath breaking have been received.
Recommended action
What to do
94 units
Product description
Complaints of the ceramic tip of the resection sheath breaking have been received.