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

Lot, batch or date codesModel 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.

Quantity recalled434 units

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.

Nationwide

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 97234

This 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
27 Aug 2025	CLASS II	Electrosurgical, Cutting and Coagulation and Accessories recalled	Olympus Corporation of the Americas	Other	Nationwide

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