Recall Z-1437-2026— Olympus Corporation of the Americas

Name: FDA recall Z-1437-2026
Creator: U.S. Food and Drug Administration
Published: 2024-09-13

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2024-09-13. It names one FDA 510(k) clearance: K790071. Product: Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;. Reason: Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2024-09-13
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 Cystoscope Outer Sheath; Model/Catalog number: WA22810A;

Reason for recall

Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.

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