FDA recall Z-0424-2023

Olympus Corporation of the Americas · Class II · device

Product

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.

Distribution

US Nationwide domestic distribution.

Key facts

Status: Ongoing
Initiation date: 2022-11-04
Report date: 2022-12-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0424-2023