CLASS II ONGOING Device recall · Reported 31 Jul 2024 · FDA Enforcement Report

ESG-410 Electrosurgical Generator- In conjunction recalled

Olympus Corporation of the Americas is recalling ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories, distributed nationwide in the US. The recall was initiated on 21 Jun 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 04042761086349 Serial Numbers: 102410, 102409, 102408, 102419, 102418, 102417, 102416, 102420, 102412, 102407, 102394, 102393, 102401, 102400, 102405, 102404, 102403, 102428, 102424, 102422, 102438, 102432, 102431, 102430, 102429, 102437, 102435, 102433, 102442, 102440, 102439, 102436, 102366, 102364, 102372, 102371, 102444, 102441, 102502, 102499, 102498, 102497, 102515, 102513, 102512, 102511, 102506, 102504, 102510, 102505, 102503, 102501, 102500, 102522, 102520, 102518, 102517, 102516, 102523, 102519, 102396, 102369, 102434, 102392, 102823, 102822, 102821, 102819, 102818, 102802, 102814, 102810, 102809, 102808, 102834, 102830, 102829, 102828, 102919, 102925, 102917, 102916, 102913, 102912, 102836, 102921

Quantity recalled86

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-2415-2024
FDA event ID: 94885
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 21 Jun 2024
FDA classified: 23 Jul 2024
Reported: 31 Jul 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

21 Jun 2024	Recall initiated by company
23 Jul 2024	Classified by FDA	+32 days
31 Jul 2024	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

Electrosurgical Generators ESG-410 does not power on upon use, may result in delays in initiating treatment or prolonged surgery

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open, laparoscopic , and endoscopic surgeries Model/Catalog Number: WA91307C

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Electrosurgical Generators ESG-410 does not power on upon use, may result in delays in initiating treatment or prolonged surgery

Which lots are affected?

UDI-DI: 04042761086349 Serial Numbers: 102410, 102409, 102408, 102419, 102418, 102417, 102416, 102420, 102412, 102407, 102394, 102393, 102401, 102400, 102405, 102404, 102403, 102428, 102424, 102422, 102438, 102432, 102431, 102430, 102429, 102437, 102435, 102433, 102442, 102440, 102439, 102436, 102366, 102364, 102372, 102371, 102444, 102441, 102502, 102499, 102498, 102497, 102515, 102513, 102512, 102511, 102506, 102504, 102510, 102505, 102503, 102501, 102500, 102522, 102520, 102518, 102517, 102516, 102523, 102519, 102396, 102369, 102434, 102392, 102823, 102822, 102821, 102819, 102818, 102802, 102814, 102810, 102809, 102808, 102834, 102830, 102829, 102828, 102919, 102925, 102917, 102916, 102913, 102912, 102836, 102921

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.

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