Recall Z-0424-2023— Olympus Corporation of the Americas

Name: FDA recall Z-0424-2023
Creator: U.S. Food and Drug Administration
Published: 2022-11-04

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2022-11-04. It names one FDA 510(k) clearance: K171965. Product: HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S. Reason: An incompatible HF cable may be packaged with the HF Resection Electrodes. This cable cannot be connected to the electrosurgical generator and may lead to delay or cancellation of the surgical procedure..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2022-11-04
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K171965 — Resection Electrodes with HF cableOlympus Winter & Ibe GmbH·cleared 2017-09-28

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

HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S

Reason for recall

An incompatible HF cable may be packaged with the HF Resection Electrodes. This cable cannot be connected to the electrosurgical generator and may lead to delay or cancellation of the surgical procedure.

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