FDAFDA · Food and drugs·Recall number Z-2415-2024
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
Published July 31, 2024 · Recall initiated: June 21, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Electrosurgical Generators ESG-410 does not power on upon use, may result in delays in initiating treatment or prolonged surgery
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Olympus Corporation of the Americas
- Distributor
- US Nationwide distribution.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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