The Recall Desk

FDA (Devices) recall action 97234

Olympus Corporation of the Americas recalled 2 products on 2025-08-27

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2025-08-27
Critical
0
Units
589

Why these products were 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'.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··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.

    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··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.

    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 instr
    Category
    Distribution
    0 states