Z-0424-2023Class II

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

Name: Z-0424-2023 HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S
Creator: Olympus Corporation of the Americas
Published: 2022-11-04
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2022-11-04 / Open, Classified / root cause: packaging

FDA source

Olympus Corporation of the Americas began a recall of HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S on 2022-11-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0424-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-04
Posted: 2022-12-07
Recalling firm: OLYMPUS Corporation of the Americas
Product: HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S
Product code: FJL Resectoscope
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.
Root cause tag: packaging
FDA root cause: Packaging process control
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.
Quantity in commerce: 186 boxes (930 pieces)
Distribution: US Nationwide domestic distribution.
Product codes and lots: Model Number/ UDI-DI/ Lot Number WA22602S 14042761085127 1000090824 WA22603S 14042761085134 1000092201 WA22621S 14042761085172 1000080316 WA22657S 14042761085301 1000092202

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0424-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0424-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-07

Product code FJL

K171965Class IIResection Electrodes with HF cableOlympus Winter & Ibe GmbH / cleared 2017-09-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)