Electrosurgical — Class II medical device recall Z-2338-2025
Ongoing recall by Olympus Corporation of the Americas, reported 2025-08-27, distributed nationwide. Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followe
| Recall number | Z-2338-2025 |
|---|---|
| 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 | 2025-07-25 |
| Classified | 2025-08-19 |
| Reported by FDA | 2025-08-27 |
| Distributed | Nationwide (US) |
| Quantity | 155 units |
| UPC / GTIN / UDI-DI | 04042761087698 |
| Lot numbers | ESG-410 |
| Serial numbers | 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 and 130 more |
| Model numbers | ESG-410, WA91327U |
Product
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.
Reason for recall
Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops'.
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-2338-2025. 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.