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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Olympus Corporation of the Americas
- 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'.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2338-2025
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