Olympus UES-40 Electrosurgical Unit Recalled for Overheating and Smoke
Olympus America Inc. is recalling 608 UES-40 electrosurgical units due to overheating, smoke vapors, and operational failures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device with reported hazards of overheating and smoke vapors, which pose a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Olympus America Inc. is recalling 608 units of the Olympus SurgMaster UES-40 electrosurgical unit. The recall covers all serial numbers prior to 7925334 that have not been upgraded. These devices are designed for use in medical facilities under the supervision of a trained physician for general and endoscopic surgery.
The recall was initiated following complaints of overheating, smoke vapors, and failure to operate when the UES-40 was used in conjunction with the Olympus WA22557C electrode. Investigations into these complaints revealed issues that led to the initiation of a software upgrade and enhancement in 2009, which was completed in 2010.
The affected units were distributed nationwide in the United States. Medical facilities should stop using the affected units and contact Olympus America Inc. for further instructions regarding the software upgrade or replacement.
The recalled product
- Product
- Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: Designed for use in a medical facility under the supervision of a trained physician. It has been designed for general (open) and endoscopic surgery including urology, gynecology, respiratory and…
- Manufacturer
- Olympus America Inc.
- Affected units
- 608
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model UES-40
- all serial numbers prior to 7925334 that have not been upgraded.
Distribution
Related recalls
Same manufacturer · Olympus America Inc.
See all →- ModerateOlympus TJF-Q180V Duodenoscope Recall Issued for Revised Reprocessing Procedures
FDA (Devices) · 2015-09-30
- HighOlympus Recalls Thunderbeat Surgical Instruments Due to Component Damage
FDA (Devices) · 2013-12-11
- HighOlympus Endoscopic Flushing Pump Recalled for Potential Standby Mode Failure
FDA (Devices) · 2013-11-27
Same hazard · overheating
See all →- Severe3M Recalls Scotch Thermal Laminators Due to Fire Hazard
CPSC · 2026-10-15
- SevereIntellijoint Navigation Systems Recalled for Potential Fire Risk
FDA (Devices) · 2026-10-14
- CriticalINMO Air3 Smart Glasses Recalled for Overheating Burn Hazard
CPSC · 2026-09-24
- HighGentherm Medical Recalls Blanketrol III Thermal Regulating Systems
FDA (Devices) · 2026-08-26
- ModerateGentherm Medical Recalls Blanketrol II Thermal Regulating Systems
FDA (Devices) · 2026-08-26
Similar recalls
- HighElectrosurgical Generators Olympus ESG-410 May Fail to Power On
FDA (Devices) · 2024-07-31
- SevereOlympus High Flow Insufflation Unit Recalled Due to Software Overpressure Risk
FDA (Devices) · 2026-02-25
- HighOlympus Ultrasound Endoscope Recall for Updated Cleaning Instructions
FDA (Devices) · 2020-12-09
- SevereOlympus High Flow Insufflation Unit Recalled Due to Software Algorithm Issue
FDA (Devices) · 2026-02-25
- CriticalOlympus High Flow Insufflation Unit Model UHI-2 Recalled Due to Software Issue
FDA (Devices) · 2026-02-25
- HighOlympus OER-Pro Endoscope Reprocessor Recall Issued for Cleaning Instructions
FDA (Devices) · 2016-10-26