Olympus Corporation Of The Americas: Electrosurgical, Cutting & Coagulation & Accessories
Olympus is recalling PKS Cutting Forceps (5mm, 33cm model 920005PK) used in electrosurgical procedures because welds in the device components were not properly validated by the supplier, which could cause the forceps' jaw to break during use. The affected forceps were distributed worldwide, including throughout the United States, Canada, Mexico, Europe, Australia, and Asia. This is a Class II recall.
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK 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.
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-02-25
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/b5ad4cbd-88df-450e-a484-97c32188cea8