Recall Weekly
Serious riskFDA DeviceClass II

Olympus Everest Bipolar Cutting Forceps recalled for jaw fracture risk

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.

From the FDA notice · Read the official notice ↗ · All Olympus recalls

What to do

  1. Stop using affected units immediately
  2. Check if you have Model 3006 Everest Bipolar Cutting Forceps with unexpired lot numbers
  3. Contact your Olympus distributor or representative for replacement or instructions
  4. Review your inventory for any units distributed to your facility
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
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.
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 7 products — see all of them.

Details

Units affected
164 units
Illnesses reported
None reported
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Classification
Class II
Recall number
Z-1639-2026

In the FDA's words

Description
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. 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. Model: 3006; UDI: 00821925035898; Lot Numbers: All unexpired; Distribution: Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan. Affected quantity: 164 units
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.

7 products in this recall

Olympus cutting forceps recalled for jaw breakage risk

Olympus is recalling seven models of bipolar and PK/PKS cutting forceps, 3,788 units in total, used in medical procedures. The supplier did not adequately validate a welding process for components, and defective welds could cause the forceps' jaw to break during clinical use. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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