Official recall notice
FDA DeviceClass IINotable
FDA Recall: Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
- 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
118 units
Product description
Complaints of the ceramic tip of the resection sheath breaking have been received.