Medical device recalls Moderate risk

Olympus Corporation of the Americas recalls Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. Th…

Recall date
July 25, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2339-2025
FDA classification
Class II
Brand / firm
Olympus Corporation of the Americas
Sold / distributed
US Nationwide distribution.

Why it was recalled

Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops'.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

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