Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment i...

FDA Recall #Z-1438-2026 — Class II — November 11, 2025

Recall #Z-1438-2026 Date: November 11, 2025 Classification: Class II Status: Ongoing

Product Description

Olympus Resection Sheath. Model No. A22014A and A22014T. 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

29 units

Distribution

US Nationwide Distribution.

Code Information

Model: A22014A (UDI: 04042761020893) and A22014T (UDI: 04042761020909). All lots.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated