HF Resection Electrodes, Model Numbers WA22602S, WA22603S… recallZ-0424-2023 · Olympus Corporation of the Americas · initiated Nov 4, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Packaging process control
What the company is doing
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.
Recall details
- Recall number
- Z-0424-2023
- Status
- Open, Classified
- Initiated by the company
- Nov 4, 2022
- Posted by the FDA
- Dec 7, 2022
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 186 boxes (930 pieces)
- Product code
- FJL
- FDA submissions
- K171965
- Distribution
- US Nationwide domestic distribution.
Product description
HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S
Code information (models, lots, serial numbers)
Model Number/ UDI-DI/ Lot Number WA22602S 14042761085127 1000090824 WA22603S 14042761085134 1000092201 WA22621S 14042761085172 1000080316 WA22657S 14042761085301 1000092202
Devices named in this recall
4 devices in the FDA device registry whose identifier appears in the recall's code information.
- Olympus WA22603SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall7 reports
- Olympus WA22621SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall4 reports
- Olympus WA22657SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
- Olympus WA22602SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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