FDA Medical devices recall ·
Electrosurgical, Cutting and Coagulation and Accessories recall
- Recall number
- Z-2338-2025
- Date
- (initiated July 25, 2025)
- Company / brand
- Olympus Corporation of the Americas
3500 Corporate Pkwy, Center Valley, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 155 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
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'.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2338-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.