HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S
Summary
The FDA issued a Class II for HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S by Olympus Corporation of the Americas. Reason: An incompatible HF cable may be packaged with the HF Resection Electrodes. This cable cannot be connected to the electrosurgical generator and may lea.
Details
Source
Device Recall
External ID
Z-0424-2023
Action Date
2022-12-14
Status
Ongoing
Category
device
Product Description
HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S
Lot/Code Info: Model Number/ UDI-DI/ Lot Number WA22602S 14042761085127 1000090824 WA22603S 14042761085134 1000092201 WA22621S 14042761085172 1000080316 WA22657S 14042761085301 1000092202
Quantity Affected: 186 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.
Distribution
US Nationwide domestic distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-04
Company
Center Valley, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 176 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Olympus Corporation of the Americas) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Olympus Corporation of the Americas have FDA actions?
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0424-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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