HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S
FDA Recall Z-0424-2023 · Posted 2022-12-07
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Recalling FirmOlympus Corporation of the Americas
Recall StatusOpen, Classified
Product CodeFJL
Date Initiated2022-11-04
Product Quantity186 boxes (930 pieces)
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.
Firm Action
On November 4, 2022, the firm notified affected customers.
Customers were instructed to identify any affected product in their inventory. Affected product should be returned to Olympus, who will issue a credit to the customer upon return of affected product. Those who have distributed the devices outside their facility should notify their customers of this removal action immediately.
To return product, contact your Olympus customer service representative at 1-800-848-9024.
Root Cause
Packaging process control
Distribution Pattern
US Nationwide domestic distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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