Olympus Everest Bipolar Cutting Forceps, Defective Weld Recall
Summary
FDA classified a Class II recall of Olympus Everest Bipolar Cutting Forceps (Model 3006) due to defective welds. Olympus identified that the supplier did not adequately validate the welding process for components in the forceps. Defective welds can cause the forceps' jaw to break during clinical use. The affected products were distributed worldwide including the US, Canada, Mexico, EU, Australia, China, Singapore, Korea, and Japan.
What changed
Olympus initiated a Class II recall of its Everest Bipolar Cutting Forceps (Model 3006) after discovering that component welds were not adequately validated by the supplier. The defect poses a risk that the forceps' jaw may break during surgical procedures, potentially endangering patients and disrupting operations.
Healthcare providers and facilities using these surgical forceps should identify affected inventory, quarantine the devices, and contact Olympus Corporation of the Americas for return or replacement instructions. The recall affects devices distributed both domestically in the US and internationally to Canada, Mexico, EU, Australia, China, Singapore, Korea, and Japan.
What to do next
- Identify affected Olympus Everest Bipolar Cutting Forceps Model 3006
- Quarantine and cease use of affected devices
- Contact Olympus for return/replacement instructions
Archived snapshot
Apr 11, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Olympus Corporation of the Americas
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1639-2026 · 20260401 · Ongoing
Product
Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3006 Product Description: The OLYMPUS Everest Bipolar Cu...
Reason for Recall
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Distribution
Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.
Source: openFDA Enforcement API
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