Olympus Everest Bipolar Cutting Forceps Welding Defect Recall
Summary
Olympus Corporation of the Americas initiated a Class II recall of Everest Bipolar Cutting Forceps (Model 3005) due to inadequate supplier welding process validation. The defect can cause the forceps' jaw to break during clinical use, posing patient safety risks. Affected products were distributed worldwide including the US, Canada, Mexico, EU, Australia, China, Singapore, Korea, and Japan.
What changed
Olympus initiated a Class II medical device recall for Everest Bipolar Cutting Forceps (Model 3005) after discovering that the supplier failed to adequately validate the welding process for critical components. The defective welds can result in the forceps' jaw breaking during surgical procedures, presenting a significant patient safety hazard.
Healthcare facilities worldwide that have purchased or use these bipolar cutting forceps must immediately discontinue use, quarantine all affected inventory, and contact Olympus to arrange returns. The recall affects units distributed across the US, Canada, Mexico, EU, Australia, China, Singapore, Korea, and Japan. Facilities should verify their inventory against model number 3005 and act promptly to mitigate risk of patient injury during procedures.
What to do next
- Immediately identify and quarantine all Olympus Everest Bipolar Cutting Forceps Model 3005 in your facility
- Cease use of affected devices pending return to Olympus
- Contact Olympus Corporation of the Americas to arrange product return and replacement
Archived snapshot
Apr 10, 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-1638-2026 · 20260401 · Ongoing
Product
Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: The OLYMPUS Everest Bipolar Cutting ...
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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