FDAHealthFebruary 25, 2026
Olympus Corporation of the Americas — Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: T
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- February 25, 2026
Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.
What's affected?
- 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 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.
- Lot code
- All
Additional details
Model: 3005; UDI: 00821925035881; Lot Number: All unexpired
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 106 units.
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