FDA DeviceClass IINotable

FDA Recall: Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.

Name: FDA Recall: Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.
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

899 units

View original recall →