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

Recall Insight

This FDA Devices action (record #Z-1277-2013) was formally reported on May 15, 2013, with the manufacturer initiating the action on November 10, 2009. It is classified under Moderate severity (Class II), with a current status of Terminated. Olympus America Inc. is listed as the recalling firm, operating out of Center Valley, PA. Federal records list the affected scope as 608.

The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: Nationwide Distribution - USA Nationwide including the states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, W…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.