Olympus Electrosurgical Generator ESG-410 Recalled for Audio Buffer System Error
Olympus Corporation recalls 279 units of its ESG-410 electrosurgical generator nationwide due to increased complaints of system error E1226 (Could not write to Audio Buffer) occurring during surgical procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II medical device recall with documented system malfunction occurring during procedures, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported. No hospitalizations, injuries, or deaths are mentioned in the source text.
Plain-English summary
Olympus Corporation of the Americas is recalling 279 units of the Olympus Electrosurgical Generator, Model ESG-410 (SEP) Version WA91327U. The affected units are distributed nationwide.
The recall was initiated following an increase in complaints of system error E1226, "Could not write to Audio Buffer," occurring during surgical procedures. This error has been documented in devices bearing the specific serial numbers referenced in the recall.
Healthcare facilities using the affected devices should refer to the FDA recall notice (Z-0264-2025) and contact Olympus Corporation of the Americas for guidance regarding next steps and options for replacement or repair.
The recalled product
- Product
- Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 279
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 (1)
- UDI-DI: 04042761087698
Distribution
Distributed nationwide across the United States.
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