Recall Z-1454-2026— Olympus Corporation of the Americas

Name: FDA recall Z-1454-2026
Creator: U.S. Food and Drug Administration
Published: 2025-11-11

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2025-11-11. It names one FDA 510(k) clearance: K790071. Product: Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.. Reason: Complaints of the ceramic tip of the resection sheath breaking have been received..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2025-11-11
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K790071 — ENDOSCOPE AND ACCESSORIESOlympus Corp.·cleared 1979-04-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.