FDAClass IIDecember 14, 2022

HF Resection Electrodes recall

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

Why was HF Resection Electrodes recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model Number/ UDI-DI/ Lot Number WA22602S 14042761085127 1000090824 WA22603S 14042761085134 1000092201 WA22621S 14042761085172 1000080316 WA22657S 14042761085301 1000092202

Product
HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S
Recalling firm
Olympus Corporation of the Americas
Quantity
186 boxes (930 pieces)
Distribution
US Nationwide domestic distribution.
Recall date
December 14, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls