Recall Z-0424-2023 ยท FJL Resectoscope
Olympus Corporation of the Americas
HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S
| Date | Dec 7, 2022 (initiated Nov 4, 2022) |
| Status | Open, Classified |
| Reason | 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 | 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 | 186 boxes (930 pieces) |
| Distribution | US Nationwide domestic distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171965 | Resection Electrodes with HF cable Olympus Winter & Ibe GmbH, Sep 28, 2017 |