FDAClass IIJuly 31, 2024

ESG-410 Electrosurgical Generator- In conjunction with recall

ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open…

Why was ESG-410 Electrosurgical Generator- In conjunction with recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models 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

Product
ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open…
Recalling firm
Olympus Corporation of the Americas
Quantity
86
Distribution
US Nationwide distribution.
Recall date
July 31, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls