FDA-Device2026-04-01Class IIPROCESSING DEFECT

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

OTHERNationwide distributionMedical devices

What this means

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.

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

The agency's original wording

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

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

Affected count

2648 units

Manufactured in

3500 Corporate Pkwy, Center Valley, PA, United States

Products

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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1641-2026

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