FDA DeviceClass IINotable

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

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

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