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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 Corporation of the Americas: ESG-410 Electrosurgical Generators Recalled for Power Failures

Agency Publication Date: July 23, 2024
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Summary

Olympus is recalling 86 units of the ESG-410 Electrosurgical Generator because the devices may fail to power on when needed. This equipment is used during various types of surgeries, including open, laparoscopic, and endoscopic procedures, to cut and coagulate tissue. If the generator does not turn on, it can lead to critical delays in starting treatment or result in prolonged surgery time while a replacement is found. Consumers should contact their healthcare provider or Olympus for further instructions regarding this equipment.

Risk

The generator may fail to power on due to an internal defect, which can cause surgical delays or prolonged anesthesia for patients already on the operating table. While no specific injuries were mentioned in this report, delays in surgical procedures pose a medium risk to patient safety.

What You Should Do

  1. Identify if your medical facility is using the ESG-410 Electrosurgical Generator by checking the model number WA91307C and the UDI-DI 04042761086349.
  2. Check the serial number on the device to see if it matches any of the following 86 affected codes: 102410, 102409, 102408, 102419, 102418, 102417, 102416, 102420, 102412, 102407, 102394, 102393, 102401, 102400, 102405, 102404, 102403, 102428, 102424, 102422, 102438, 102432, 102431, 102430, 102429, 102437, 102435, 102433, 102442, 102440, 102439, 102436, 102366, 102364, 102372, 102371, 102444, 102441, 102502, 102499, 102498, 102497, 102515, 102513, 102512, 102511, 102506, 102504, 102510, 102505, 102503, 102501, 102500, 102522, 102520, 102518, 102517, 102516, 102523, 102519, 102396, 102369, 102434, 102392, 102823, 102822, 102821, 102819, 102818, 102802, 102814, 102810, 102809, 102808, 102834, 102830, 102829, 102828, 102919, 102925, 102917, 102916, 102913, 102912, 102836, or 102921.
  3. If you possess an affected generator, contact your healthcare provider or Olympus Corporation of the Americas at 3500 Corporate Pkwy, Center Valley, PA 18034-8229 for technical support and instructions.
  4. For additional information or to report concerns, contact the FDA directly at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Support

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: ESG-410 Electrosurgical Generator
Model / REF:
WA91307C
UPC Codes:
04042761086349
Lot Numbers (86):
102410
102409
102408
102419
102418
102417
102416
102420
102412
102407
102394
102393
102401
102400
102405
102404
102403
102428
102424
102422
102438
102432
102431
102430
102429
102437
102435
102433
102442
102440
102439
102436
102366
102364
102372
102371
102444
102441
102502
102499
102498
102497
102515
102513
102512
102511
102506
102504
102510
102505

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94885
Status: Active
Manufacturer: Olympus Corporation of the Americas
Sold By: Olympus Corporation of the Americas
Manufactured In: United States
Units Affected: 86
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.