Olympus Corporation of the Americas recalled 93 PKS Cutting Forceps worldwide due to welding defects that can cause the jaw to break during clinical use. The issue involves Model 3005PK and UDI 00821925036000. Action is required immediately and providers should follow recall instructions.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter
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Model: 3005PK\nUDI: 00821925036000\nLot Numbers: All unexpired\nQuantity: 93 units\nSold worldwide: US, Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan\nRecall date: 2026-02-25\nManufacturer: Olympus Corporation of the Americas\nRemedy: Stop using the device and follow recall instructions. Contact Olympus or your healthcare provider for instructions.
The device contains components with a welding process that was not adequately validated by the supplier. Defective welds can cause the jaw to break during clinical use.
No injuries or incidents have been reported.
1. Stop using the device. 2. Do not use with patients. 3. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. 4. Refund or replacement details will be provided by Olympus Corporation of the Americas.
Refund information and recall instructions are managed by Olympus Corporation of the Americas. Website: https://www.olympusamerica.com
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