Z-2415-2024Class II

ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and...

Name: Z-2415-2024 ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and...
Creator: Olympus Corporation of the Americas
Published: 2024-06-21
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2024-06-21 / Open, Classified / root cause: design

FDA source

Olympus Corporation of the Americas began a recall of ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open, laparoscopic , and... on 2024-06-21. FDA classified it as Class II and gives the reason as "Electrosurgical Generators ESG-410 does not power on upon use, may result in delays in initiating treatment or prolonged surgery". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2415-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-21
Posted: 2024-07-23
Recalling firm: OLYMPUS Corporation of the Americas
Product: 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
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Electrosurgical Generators ESG-410 does not power on upon use, may result in delays in initiating treatment or prolonged surgery
Root cause tag: design
FDA root cause: Component design/selection
Action: Olympus issued URGENT: MEDICAL DEVICE REMOVAL Letter on 6/21/24. Letter states reason for recall, health risk and action to take: An Olympus representative will reach out to you to coordinate a repair to replace the power supply on your affected ESG-410 unit(s). Technical analysis of this issue performed by Olympus has determined that when the device is successfully powered on, it will work within specification. Therefore, you may continue to use your ESG-410 generator until the power supply is replaced. To minimize procedural delays, power on the generator prior to starting the procedure and, whenever possible, have a replacement device available. Additionally, Olympus requires you to take the following actions: 1. Carefully read the content of this notification. 2. If you have further distributed this product, identify your customers, and forward them this notification. 3. Acknowledge receipt of this letter through the Olympus web portal: a. Go to https://olympusamerica.com/recall Olympus requests that you report any complaints, including the ESG-410 generator not powering on, to the Technical Assistance Center (TAC) at 1- 800-848-9024 (option 1). If you require additional information, please do not hesitate to contact me by phone at (647) 999-3203 from Monday through Friday, 9 am to 5 pm EDT, or by e-mail at [email protected].
Quantity in commerce: 86
Distribution: US Nationwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2415-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2415-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-31	2024-07-23

Product code GEI

K203277Class IIElectrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH / cleared 2021-04-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)