Recall Weekly
Serious riskFDA DeviceClass II

Olympus HALO PKS Cutting Forceps recalled for defective welds causing jaw breakage

Olympus discovered that some HALO PKS Cutting Forceps (model HACF0533) have defective welds in their components. During surgery, the forceps' jaw can break when the welds fail, potentially affecting the procedure. This affects medical facilities worldwide that use these surgical instruments with the Gyrus ACMI G400 Workstation.

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

What to do

  1. Stop using HALO PKS Cutting Forceps model HACF0533 immediately
  2. Contact your hospital or surgical facility's device coordinator if you have these forceps
  3. Do not use affected instruments until you receive guidance from Olympus or the FDA
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: The HALO PKS Cutting Forceps are intended to be passed through a 5 mm laparoscopic cannula. Coagulation is achieved using electrosurgical energy under laparoscopic visualization. The device is intended to be used with the Gyrus ACMI G400 Workstation only.
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 7 products — see all of them.

Details

Units affected
2648 units
Illnesses reported
None reported
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Classification
Class II
Recall number
Z-1641-2026

In the FDA's words

Description
Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: The HALO PKS Cutting Forceps are intended to be passed through a 5 mm laparoscopic cannula. Coagulation is achieved using electrosurgical energy under laparoscopic visualization. The device is intended to be used with the Gyrus ACMI G400 Workstation only. 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: HACF0533; UDI: 00821925036390; Lot Numbers: All unexpired; Distribution: Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan. Affected quantity: 2648 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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