Olympus Corporation of the Americas initiated Class II recall Z-1642-2026 for PKS Cutting Forceps, Model/Catalog Number 3005PK. The recall stems from a supplier manufacturing defect where welding processes were not adequately validated, potentially causing the forceps' jaw to fracture during surgical procedures. Affected products were distributed both domestically in the US and internationally to Canada, Mexico, EU, Australia, China, Singapore, Korea, and Japan.

Healthcare providers and medical facilities that have purchased or use the 3005PK Cutting Forceps must immediately check their inventory for the affected device, cease use of any suspect units, and contact Olympus for return instructions. The recall is ongoing, and failure to remove defective devices from clinical use could result in patient injury if the forceps' jaw breaks during a procedure.