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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Olympus ESG-410 Electrosurgical Generators Recalled for Reboot Loop Error

Agency Publication Date: August 19, 2025
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Summary

Olympus Corporation of the Americas is recalling approximately 589 ESG-410 Electrosurgical Generators, including both the Surgical Energy Platform (SEP) and Legacy models. These devices, used to cut and cauterize tissue during surgeries, may display a system error message followed by unexpected reboots or continuous reboot loops. This failure can cause a sudden loss of the device's surgical functions while a medical procedure is underway. Consumers should stop using affected units and contact Olympus for instructions on how to return or correct the devices.

Risk

The generator may display an 'E0662' error and shut down unexpectedly during surgery. This interruption could cause delays in medical procedures or loss of critical surgical energy, potentially requiring surgical teams to switch to backup equipment or leading to patient injury. No specific injuries have been reported in the provided data.

What You Should Do

  1. This recall affects Olympus ESG-410 Electrosurgical Generators, including the Surgical Energy Platform (model number WA91327U) and the Legacy model (model number WA91307C).
  2. To determine if your equipment is affected, locate the serial number on the identification label of the generator unit. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately to prevent interruptions during surgical procedures.
  4. Contact Olympus Corporation of the Americas or your authorized distributor to arrange for the return, replacement, or correction of the generator.
  5. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for any additional questions or concerns regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP)
Model / REF:
WA91327U
Serial Numbers (155):
101696
101697
101698
101699
101700
101701
101702
101703
101704
101705
101706
101707
101708
101709
101710
101919
101920
101921
101922
101923
101924
101925
101926
101927
101928
101929
101933
101934
101935
101936
101937
101940
101941
101942
101945
101946
101947
102148
102149
102150
102151
102152
102153
102154
102156
102157
102158
102159
102160
102161
Lot Numbers:
ESG-410 (SEP) WA91327U
UDI:
04042761087698

Recall Number: Z-2338-2025

Product: Electrosurgical Generator ESG-410 Legacy
Model / REF:
WA91307C
Serial Numbers (434):
101004
101005
101006
101007
101008
101009
101010
101011
101012
101013
101014
101015
101016
101017
101018
101019
101020
101021
101022
101023
101024
101025
101029
101030
101031
101032
101033
101034
101035
101036
101037
101038
101039
101040
101041
101042
101043
101044
101045
101046
101047
101048
101049
101050
101051
101052
101053
101054
101055
101056
Lot Numbers:
ESG-410 Legacy WA91307C
UDI:
04042761086349

Recall Number: Z-2339-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97234
Status: Active
Manufacturer: Olympus Corporation of the Americas
Sold By: Authorized medical device distributors; Specialty surgical suppliers
Manufactured In: United States
Units Affected: 2 products (155 units; 434 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.