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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PKS Cutting Forceps are surgical instruments passed through a 5mm cannula and used with electrosurgical energy under visualization. They are designed to be used with the PKS electrical generator.
Defective welds can cause the jaw to break during clinical use, posing a risk of injury to patients.
This recall is not described as part of a broader industry pattern in the provided data.
Clinicians may need to halt procedures using these forceps; facilities may face workflow disruptions and potential patient safety concerns.
Identify on device packaging, label, and accompanying documentation.
Remedy details, including refunds or replacements, will be communicated by Olympus.
Keep the recall letter, model number, UDI, lot numbers, and correspondence with Olympus for records.
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.
No injuries or incidents have been reported.
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