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Medium risk Drugs & MedicationsClass II

Olympus Corporation of the Americas Recall

Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.

Updated November 11, 2025

Olympus Corporation of the Americas is recalling Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.. Hazard: Complaints of the ceramic tip of the resection sheath breaking have been received.

Is the Olympus Corporation of the Americas recalled? Yes. This product was recalled by FDA on November 11, 2025. Details below.

What is recalled

Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

The hazard

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

Brands affected

Olympus Corporation of the Americas
Source
FDA
Category
Drugs & Medications
Recall ID
fda-Z-1454-2026
Classification
Class II
Recalled
November 11, 2025
Read the official notice

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