Olympus Corporation of the Americas 2024-11-06 Health serious FDA
Health · FDA · Recall #FDA-Z-0264-2025
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U Recall
Issued November 6, 2024 · Olympus Corporation of the Americas
In November 2024, Olympus Corporation of the Americas recalled the Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
There was an increase in complaints indicating an occurrence of system error E1226 "Could not write to Audio Buffer" during procedures using the ESG-410 (SEP).
What you should do
- 1 Stop using Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Olympus Corporation of the Americas to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Olympus Corporation of the Americas
- Category
- Health
- Recall date
- November 6, 2024
- Units affected
- Not reported
- Sold at
- US Nationwide.
- Recall number
- FDA-Z-0264-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Olympus Corporation of the Americas has 42 recalls in our database, including 6 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.