Olympus Corporation of the Americas recalled 164 Everest Bipolar Cutting Forceps worldwide on Feb. 25, 2026. A supplier welding process was not adequately validated, risking jaw breakage during surgical use. Clinicians should stop using the device and follow Olympus 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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The Everest Bipolar Cutting Forceps are passed through a 5 mm cannula and used to coagulate tissue with electrosurgical energy under visualization. The device is intended for use with compatible bipolar generators.
A welding-process validation issue can lead to defective welds. The jaw may break during clinical use, potentially injuring the patient or compromising the procedure.
This recall is not described as part of a broader industry pattern.
Hospitals may need to halt procedures using this device. A jaw breakage could require device replacement mid-procedure and impose costs on facilities.
Recall notices and instructions are available on the FDA enforcement page linked to recall Z-1639-2026 and through Olympus communications.
The recall notice does not specify a replacement or refund timeline.
Keep the recall notice, device serials/UDIs, exchange communications, and records of returns or replacements.
Model: 3006; UDI: 00821925035898; Lot Numbers: All unexpired; Sold worldwide (US, Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan); Price: Unknown.
No injuries or incidents have been reported.
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