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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97234

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 25, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Olympus Corporation of the Americas

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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.

Z-2338-2025
Recall number
Z-2338-2025
Initiated
July 25, 2025
Classification
Class II
Status
Ongoing
Quantity
155 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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'.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

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'.

Code information

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 pattern

US Nationwide distribution.

device · product 2 of 2

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.

Z-2339-2025
Recall number
Z-2339-2025
Initiated
July 25, 2025
Classification
Class II
Status
Ongoing
Quantity
434 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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'.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

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'.

Code information

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.

Distribution pattern

US Nationwide distribution.