Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological appli...
FDA Recall #Z-1455-2026 — Class II — November 11, 2025
Product Description
Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
Reason for Recall
Complaints of the ceramic tip of the resection sheath breaking have been received.
Recalling Firm
Olympus Corporation of the Americas — Center Valley, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
0 units
Distribution
US Nationwide Distribution.
Code Information
Model No. A2641; UDI: 04042761004060; All Lots.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated