Recall Ledger

Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord recall (Olympus Corporation of the Americas)

Medical deviceClass IIOngoing

Summary: Olympus Corporation of the Americas is recalling 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 electrosu. Reason: 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.

What is being recalled

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.

Why

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.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.

How to tell if yours is affected

Model: 3006; UDI: 00821925035898; Lot Numbers: All unexpired;

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-1639-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedFebruary 25, 2026
ReportedApril 1, 2026
CompanyOlympus Corporation of the Americas
Company locationCenter Valley, PA, United States
Initiated byVoluntary: Firm initiated
Quantity164 units

More recalls from Olympus Corporation of the Americas · all medical device recalls · recalls from February 2026

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