Z-0424-2023 Class II Ongoing
FDA device recall Z-0424-2023 was initiated by Olympus Corporation Of The Americas on Nov 4, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 186 boxes (930 pieces).
Recall Details
- Product Type
- Devices
- Report Date
- Dec 14, 2022
- Initiation Date
- Nov 4, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 186 boxes (930 pieces)
Product Description
HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S
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.
Distribution Pattern
US Nationwide domestic distribution.
Code Information
Model Number/ UDI-DI/ Lot Number WA22602S 14042761085127 1000090824 WA22603S 14042761085134 1000092201 WA22621S 14042761085172 1000080316 WA22657S 14042761085301 1000092202
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0424-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026