CLASS II ONGOING Device recall · Reported 27 Aug 2025 · FDA Enforcement Report
Electrosurgical, Cutting and Coagulation and Accessories recalled
Olympus Corporation of the Americas is recalling Electrosurgical, Cutting and Coagulation and Accessories, distributed nationwide in the US. The recall was initiated on 25 Jul 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2339-2025
- FDA event ID
- 97234
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Jul 2025
- FDA classified
- 19 Aug 2025
- Reported
- 27 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 25 Jul 2025 | Recall initiated by company | |
| 19 Aug 2025 | Classified by FDA | +25 days |
| 27 Aug 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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'.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution.
Questions about this recall
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'.
Which lots are affected?
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.
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 97234This product is part of a recall event; the main page for the event is Electrosurgical, Cutting and Coagulation and Accessories recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Electrosurgical, Cutting and Coagulation and Accessories recalled | Olympus Corporation of the Americas | Other | Nationwide |
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