Agency classClass IIOur severity:High FDA (Devices)·Z-2339-2025·Announced 2025-08-27

Legacy electrosurgical generators recalled over system error triggering repeated device reboots

The ESG-410 Legacy Electrosurgical Generator, model WA91307C, is recalled because it may display an E0662 System Error followed by a single automatic reboot or a continuous reboot loop. 434 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 electrosurgical generator, model number WA91307C, UDI-DI 04042761086349, is being recalled. The device is an electrosurgical generator using monopolar and bipolar high frequency current for cutting and coagulation. Affected units are identified by the serial numbers listed in the recall notice. The recall covers 434 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. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic…
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Surgical Equipment
Hazard: system-error
device-reboot
electrosurgery
class-ii
Affected units: 434

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)

101005
101006
101007
101008
101009
101010
101011
101012
101013
101014
101015
101016
101017
101018
101019
101020
101021
101022
101023
101024

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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