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RecallWatchMedical Device Safety
Class IIOngoingZ-2338-2025

Olympus Corporation Of The Americas recalls Electrosurgical

Olympus Corporation of the AmericasCenter Valley, PA, United StatesReported Aug 27, 2025 · 10 months ago
Legal News Analyst ·

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'.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    UDI-DI 04042761087698.Model Number
    158 affected lots
    ESG-410WA91327U04042761087698101696101697101698101699101700
    +150 more101701101702101703101704101705101706101707101708101709101710101919101920101921101922101923101924101925101926101927101928101929101933101934101935101936101937101940101941101942101945101946101947102148102149102150102151102152102153102154102156102157102158102159102160102161102162102164102165102167102168102170102172102173102174102175102176102177102178102179102180102181102182102183102184102185102186102187102188102189102190102191102193102194102195102198102199102200102266102427101932102155102163102197102660102661102662102663102664102665102666102667102668102669102670102671102672102673102674102675102676102677102678102679102680102681102682102683102684102685102686102687102688102689102690102691102692102693102694102695102696102697102698102699102700102701102702102703102704102705102706102707102708102709102710102711102712102713102714102715102716102717102718102719102721102722102723102724102725103922103930

What the firm is doing

Olympus notified consignees via letter on about 07/25/2025. Consignees were instructed to examine inventory, identify any affected units, and continued use is permitted until the repair is performed as long as users follow the IFU. Olympus will contact consignees to arrange for the return of affected units to replace the affected part. Consignees were also instructed to notify customers, if the units were further distributed, and to acknowledge receipt of the letter through the Olympus web portal.

DistributionShow details

US Nationwide distribution.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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