Recall Weekly
Moderate riskFDA DeviceClass II

Olympus PK Cutting Forceps recalled for defective welds causing jaw breakage

Olympus PK Cutting Forceps (model PK-CF0533) contain welding defects that can cause the instrument's jaw to break during surgical use. The supplier did not properly validate the welding process on affected components. This could compromise the forceps' function during endoscopic or open surgical procedures.

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

What to do

  1. Stop using Olympus PK Cutting Forceps model PK-CF0533 immediately
  2. Contact Olympus Corporation of the Americas for device removal or replacement instructions
  3. Check your facility's inventory for lot numbers and verify expiration status
  4. Report any injuries or device failures to the FDA MedWatch program
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An assembly of devices intended to generate and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure.
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 7 products — see all of them.

Details

Units affected
444 units
Illnesses reported
None reported
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Classification
Class II
Recall number
Z-1640-2026

In the FDA's words

Description
Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An assembly of devices intended to generate and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure. 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: PK-CF0533; UDI: 00821925035867; Lot Numbers: All unexpired; Distribution: Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan. Affected quantity: 444 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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