Medical device recalls Moderate risk

Olympus Corporation of the Americas recalls Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.

Recall date
November 11, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1448-2026
FDA classification
Class II
Brand / firm
Olympus Corporation of the Americas
Sold / distributed
US Nationwide Distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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