Agency classClass IIOur severity:High FDA (Devices)·Z-2338-2025·Announced 2025-08-27

Electrosurgical generators recalled over system error causing reboots during use

The ESG-410 Electrosurgical Generator is recalled because it may display an E0662 System Error followed by a single automatic reboot or a continuous reboot loop. 155 units are affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; a generator that reboots during a procedure could interrupt surgery, and the notice reports no injuries.

Plain-English summary

The ESG-410 Surgical Energy Platform electrosurgical generator, model number WA91327U, UDI-DI 04042761087698, is being recalled. The device is an electrosurgical generator used for monopolar and bipolar cutting and coagulation. Affected units are identified by the serial numbers listed in the recall notice. The recall covers 155 units distributed nationwide in the United States.

The recall was issued because of the potential for the generator to display the error message "E0662 System Error", followed by either an automatic single reboot of the device or a continuous reboot loop. The FDA classified the action as Class II.

Hospitals and surgical centres should check their serial numbers against the recall notice and follow the manufacturer's instructions for affected generators.

The recalled product

Product: Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency…
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Surgical Equipment
Hazard: system-error
device-reboot
electrosurgery
class-ii
Affected units: 155

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

101697
101698
101699
101700
101701
101702
101703
101704
101705
101706
101707
101708
101709
101710
101919
101920
101921
101922
101923
101924

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Olympus Corporation of the Americas

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