FDA-Device2026-04-01Class IIPROCESSING DEFECT
Olympus Everest Bipolar Cutting Forceps recalled for jaw fracture risk
OTHERNationwide distribution
Stop using Olympus Everest Bipolar Cutting Forceps
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
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.
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 Corporation of the Americas recalls
- FDA-Device2026-04-08Olympus SOLTIVE Premium laser system recalled for defective power supply
- FDA-Device2026-04-08Olympus SOLTIVE Pro SuperPulsed Laser System recalled for power supply defect
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
- FDA-Device2026-04-01Olympus MAJ-1443 and MAJ-1444 endoscope suction valves no longer compatible with OER-Pro and OER-Elite reprocessors
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
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