Olympus Electrosurgical Generator — Class II medical device recall Z-0264-2025
Ongoing recall by Olympus Corporation of the Americas, reported 2024-11-06, distributed nationwide. There was an increase in complaints indicating an occurrence of system error E1226 "Could not write to Audio B
| Recall number | Z-0264-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2024-09-04 |
| Classified | 2024-10-30 |
| Reported by FDA | 2024-11-06 |
| Distributed | Nationwide (US) |
| Quantity | 279 units |
| UPC / GTIN / UDI-DI | 04042761087698 |
| Serial numbers | 101698, 101702, 101920, 101923, 101925, 101929, 101932, 101933, 101934, 101937, 101945, 101947, 102149, 102150, 102153, 102154, 102155, 102156, 102159, 102161, 102162, 102163, 102164, 102167, 102168 and 254 more |
| Model numbers | ESG-410 |
Product
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
Reason for recall
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0264-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.