FDAHealthFebruary 25, 2026

Olympus Corporation of the Americas — Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: The HALO PKS

⚠️ 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.

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: February 25, 2026

Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.

What's affected?

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.
Brand: Olympus Corporation of the Americas
Lot code: All

Additional details

Model: HACF0533; UDI: 00821925036390; Lot Numbers: All unexpired;

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 2648 units.

View original FDA notice →

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