FDA Enforcement
Class II
Ongoing
Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
Recall: Z-1455-2026
·
Reported March 4, 2026
Enforcement
- Recall Number
- Z-1455-2026
- Event ID
- 98288
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Olympus Corporation of the Americas
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 4, 2026
- Initiation Date
- November 11, 2025
- Classification Date
- February 20, 2026
- Address
- 3500 Corporate Pkwy, N/A, Center Valley, PA, 18034-8229, United States
Description
Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
Reason
Complaints of the ceramic tip of the resection sheath breaking have been received.
Code Info
Model No. A2641; UDI: 04042761004060; All Lots.
Distribution
US Nationwide Distribution.
Quantity
0 units