Class IIReported 2026-03-04

Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.

Recalled by Olympus Corporation of the Americas

Reason for Recall

Complaints of the ceramic tip of the resection sheath breaking have been received.

Recall Number

Z-1455-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-11-11

Reported

2026-03-04

Distribution

US Nationwide Distribution.

Code Info

Model No. A2641; UDI: 04042761004060; All Lots.

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.