The Recall Desk
Severity pendingFDA (Devices)·Z-2338-2025·Announced 2025-08-27

Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical

Pending LLM rewrite. Source: FDA_DEVICE Z-2338-2025.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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'.

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 current
Manufacturer
Olympus Corporation of the Americas

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.