FDA-Device2026-04-01Class IIPROCESSING DEFECT
Olympus Everest Bipolar Cutting Forceps recalled for jaw fracture risk
What this means
Olympus discovered that some Everest Bipolar Cutting Forceps (Model 3006) have welding defects in internal components. These defects can cause the forceps' jaw to break during surgery, potentially requiring additional procedures or intervention.
- Stop using affected units immediately
- Check if you have Model 3006 Everest Bipolar Cutting Forceps with unexpired lot numbers
- Contact your Olympus distributor or representative for replacement or instructions
- Review your inventory for any units distributed to your facility
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.
Affected count
164 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
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 Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1639-2026More Olympus recalls
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