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Moderate riskFDA DeviceClass II

Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage

Olympus PKS Cutting Forceps (Model 920000PK) contain welding defects that can cause the instrument's jaw to break during surgery. The supplier did not properly validate the welding process on affected components. This affects 7 units distributed worldwide.

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

What to do

  1. Stop using the Olympus PKS Cutting Forceps Model 920000PK immediately.
  2. Contact Olympus Corporation of the Americas for instructions on return or replacement.
  3. Verify your device lot number matches the recall—all unexpired lots are affected.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 7 products — see all of them.

Details

Units affected
7 units
Illnesses reported
None reported
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Classification
Class II
Recall number
Z-1643-2026

In the FDA's words

Description
Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator. 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: 920000PK; UDI: 00821925038080; Lot Numbers: All unexpired; Distribution: Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan. Affected quantity: 7 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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