FDA DeviceClass IINotable

FDA Recall: Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological appl

Name: FDA Recall: Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological appl
Brand: Olympus Corporation of the Americas

Date: 2026-03-04

Brand: Olympus Corporation of the Americas

Category: Medical Device

FDA Class: Class II

Description

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

Hazard

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

Remedy

94 units

View original recall →