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Electrosurgical, Cutting and Coagulation and Accessories.… recallZ-2339-2025 · Olympus Corporation of the Americas · initiated Jul 25, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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'.

FDA root cause category: Component change control

What the company is doing

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.

Recall details

Recall number
Z-2339-2025
Status
Open, Classified
Initiated by the company
Jul 25, 2025
Posted by the FDA
Aug 19, 2025
Recalling firm
Olympus Corporation of the Americas
Quantity
434 units
Product code
GEI
FDA submissions
K203277
Distribution
US Nationwide distribution.

Product description

Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. 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.

Code information (models, lots, serial numbers)

Show the full code information (4k characters)

Model Number: WA91307C. Lot Code: ESG-410 Legacy WA91307C. UDI-DI: 04042761086349. Serial Numbers: 101004, 101005, 101006, 101007, 101008, 101009, 101010, 101011, 101012, 101013, 101014, 101015, 101016, 101017, 101018, 101019, 101020, 101021, 101022, 101023, 101024, 101025, 101029, 101030, 101031, 101032, 101033, 101034, 101035, 101036, 101037, 101038, 101039, 101040, 101041, 101042, 101043, 101044, 101045, 101046, 101047, 101048, 101049, 101050, 101051, 101052, 101053, 101054, 101055, 101056, 101057, 101058, 101059, 101060, 101061, 101062, 101063, 101064, 101066, 101067, 101068, 101069, 101070, 101071, 101072, 101073, 101074, 101238, 101239, 101240, 101241, 101242, 101243, 101244, 101245, 101246, 101247, 101250, 101251, 101252, 101253, 101254, 101255, 101256, 101257, 101258, 101259, 101260, 101261, 101262, 101263, 101264, 101265, 101266, 101267, 101268, 101269, 101270, 101271, 101272, 101273, 101274, 101275, 101276, 101277, 101278, 101279, 101280, 101281, 101282, 101283, 101284, 101285, 101286, 101287, 101288, 101289, 101290, 101291, 101292, 101293, 101294, 101295, 101296, 101297, 101298, 101299, 101300, 101301, 101302, 101333, 101334, 101335, 101336, 101337, 101338, 101339, 101340, 101341, 101342, 101370, 101371, 101372, 101373, 101374, 101375, 101376, 101377, 101378, 101379, 101395, 101396, 101397, 101398, 101399, 101400, 101401, 101402, 101403, 101432, 101433, 101434, 101435, 101436, 101437, 101438, 101439, 101440, 101441, 101613, 101633, 101634, 101635, 101636, 101637, 101638, 101684, 101685, 101686, 101687, 101688, 101689, 101691, 101690, 101692, 101693, 101694, 101695, 101743, 101744, 101745, 101746, 101747, 101748, 101749, 101750, 101751, 101752, 101753, 101754, 101755, 101756, 101757, 101758, 101759, 101760, 101761, 101762, 101763, 101764, 101765, 101766, 101767, 101768, 101769, 101770, 101771, 101772, 101773, 101774, 101775, 101776, 101777, 101778, 101779, 101780, 101781, 101782, 101783, 101784, 101785, 101786, 101787, 101788, 101789, 101958, 101959, 101960, 101961, 101962, 101963, 101964, 101965, 101966, 101967, 101968, 101969, 101970, 101971, 102017, 102018, 102019, 102020, 102021, 102024, 102025, 102026, 102027, 102028, 102055, 102056, 102057, 102058, 102059, 102060, 102061, 102062, 102063, 102064, 102065, 102066, 102067, 102068, 102069, 102284, 102285, 102286, 102287, 102288, 102289, 102290, 102291, 102292, 102293, 102294, 102295, 102296, 102297, 102298, 102299, 102300, 102301, 102302, 102303, 102304, 102305, 102306, 102307, 102308, 102309, 102310, 102311, 102312, 102313, 102314, 102315, 102316, 102317, 102318, 102319, 102320, 102321, 102323, 102325, 102326, 102327, 102328, 102329, 102330, 102331, 102332, 102333, 102334, 102335, 102362, 102363, 102364, 102366, 102367, 102368, 102369, 102370, 102371, 102372, 102373, 102391, 102392, 102393, 102394, 102395, 102396, 102397, 102399, 102400, 102401, 102402, 102403, 102404, 102405, 102406, 102407, 102408, 102409, 102410, 102411, 102412, 102413, 102414, 102415, 102416, 102417, 102418, 102419, 102420, 102421, 102422, 102423, 102424, 102425, 102426, 102428, 102429, 102430, 102431, 102432, 102433, 102434, 102435, 102436, 102437, 102438, 102439, 102440, 102441, 102442, 102443, 102444, 102445, 102497, 102498, 102499, 102500, 102501, 102502, 102503, 102504, 102505, 102506, 102507, 102508, 102509, 102510, 102511, 102512, 102513, 102515, 102516, 102517, 102518, 102519, 102520, 102521, 102522, 102523, 102802, 102807, 102808, 102809, 102810, 102814, 102818, 102819, 102820, 102821, 102822, 102823, 102828, 102829, 102830, 102831, 102832, 102834, 102836, 102837.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

1 device cleared under K203277 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 97234).

Sources and updates

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