Recall Z-0351-2025— Olympus Corporation of the Americas

Name: FDA recall Z-0351-2025
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: Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths can be combined with rigid Telescopes. Component: N/A. Reason: Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a damaged tip during use of a laser probe..

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

Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths can be combined with rigid Telescopes. Component: N/A

Reason for recall

Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a damaged tip during use of a laser probe.

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