Olympus SurgMaster UES-40 electrosurgical unit — Class II medical device recall Z-1277-2013
Terminated recall by Olympus America Inc., reported 2013-05-15, distributed nationwide. Olympus initiated a software upgrade and enhancement in 2009 and completed the action in 2010. The upgrade and
| Recall number | Z-1277-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus America Inc., Center Valley, PA, United States |
| Recall initiated | 2009-11-10 |
| Classified | 2013-05-08 |
| Reported by FDA | 2013-05-15 |
| Terminated | 2013-07-05 |
| Distributed | Nationwide (US) |
| Quantity | 608 |
| Reason classes | device malfunction, software |
| Model numbers | UES-40 |
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 gastroenterology in conjunction with Olympus designed electrosurgical accessories, endoscopes (fiberscopes, videoscopes and rigid scopes) applicable for electrosurgery (cutting and coagulation), light sources and other ancillary equipment.
Reason for recall
Olympus initiated a software upgrade and enhancement in 2009 and completed the action in 2010. The upgrade and enhancement were initiated due to complaints of overheating, smoke vapors and failure to operate associated with the Olympus SurgMaster electrosurgical unit, model UES-40 ("UES-40") when used in conjunction with the Olympus WA22557C electrode. The complaint investigations revealed that
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1277-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.