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Moderate riskFDA DeviceClass II

Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage

Olympus Corporation has recalled its PKS Cutting Forceps (Model 3005PK) used during minimally invasive surgery. The device contains components with defective welds that were not properly validated by the supplier. If the jaw breaks during use, it could affect the procedure and patient safety.

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

What to do

  1. Stop using Olympus PKS Cutting Forceps Model 3005PK immediately
  2. Contact your facility's surgical equipment manager or Olympus directly for instructions on device replacement or return
  3. Review your inventory for affected units (all unexpired lots are included)
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK 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
93 units
Illnesses reported
None reported
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Classification
Class II
Recall number
Z-1642-2026

In the FDA's words

Description
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK 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: 3005PK; UDI: 00821925036000; Lot Numbers: All unexpired; Distribution: Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan. Affected quantity: 93 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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