Z-2338-2025Class II

Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy...

Name: Z-2338-2025 Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy...
Creator: Olympus Corporation of the Americas
Published: 2025-07-25
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2025-07-25 / Open, Classified

FDA source

Olympus Corporation of the Americas began a recall of Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410... on 2025-07-25. FDA classified it as Class II and gives the reason as "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'". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2338-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-25
Posted: 2025-08-19
Recalling firm: OLYMPUS Corporation of the Americas
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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'.
FDA root cause: Component change control
Action: Olympus notified consignees via letter on about 07/25/2025. Consignees were instructed to examine inventory, identify any affected units, and continued use is permitted until the repair is performed as long as users follow the IFU. Olympus will contact consignees to arrange for the return of affected units to replace the affected part. Consignees were also instructed to notify customers, if the units were further distributed, and to acknowledge receipt of the letter through the Olympus web portal.
Quantity in commerce: 155 units
Distribution: US Nationwide distribution.
Product codes and lots: Model Number: WA91327U. Lot Code: ESG-410 (SEP) WA91327U. UDI-DI: 04042761087698. 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, 101929, 101933, 101934, 101935, 101936, 101937, 101940, 101941, 101942, 101945, 101946, 101947, 102148, 102149, 102150, 102151, 102152, 102153, 102154, 102156, 102157, 102158, 102159, 102160, 102161, 102162, 102164, 102165, 102167, 102168, 102170, 102172, 102173, 102174, 102175, 102176, 102177, 102178, 102179, 102180, 102181, 102182, 102183, 102184, 102185, 102186, 102187, 102188, 102189, 102190, 102191, 102193, 102194, 102195, 102198, 102199, 102200, 102266, 102427, 101932, 102155, 102163, 102197, 102660, 102661, 102662, 102663, 102664, 102665, 102666, 102667, 102668, 102669, 102670, 102671, 102672, 102673, 102674, 102675, 102676, 102677, 102678, 102679, 102680, 102681, 102682, 102683, 102684, 102685, 102686, 102687, 102688, 102689, 102690, 102691, 102692, 102693, 102694, 102695, 102696, 102697, 102698, 102699, 102700, 102701, 102702, 102703, 102704, 102705, 102706, 102707, 102708, 102709, 102710, 102711, 102712, 102713, 102714, 102715, 102716, 102717, 102718, 102719, 102721, 102722, 102723, 102724, 102725, 103922, 103930.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2338-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2338-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-27	2025-08-19
Z-2339-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-27	2025-08-19

Product code GEI

K231777Class IIElectrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)Olympus Winter & Ibe GmbH / cleared 2023-08-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)