ModerateClass IITerminated

FDA Devices recall · Reported May 15, 2013

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

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on May 15, 2013. Severity: Moderate. Recall number: Z-1277-2013.

Q: Where was the recalled product distributed?

Distribution: 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, WA, WV, and WY..

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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 …

Recall #: Z-1277-2013
Affected scope: 608
Initiated: November 10, 2009

Compiled from official public sources by the publisher. · Updated September 2026

Verify with FDA Devices →

View my saved recalls

Olympus America Inc. recalled Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: Designed for… - a moderate-severity action.

Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: Designed for… was recalled by Olympus America Inc. in May 15, 2013. Reason: Olympus initiated a software upgrade and enhancement in 2009 and completed the action in 2010. The upgrade a…. Check the official notice for the remedy. Verify recall #Z-1277-2013 with the FDA Devices before acting.

The recall

Olympus America Inc. issued this moderate-severity FDA Devices recall-Olympus initiated a software upgrade and enhancement in 2009 and completed the action in 2010. The upgrade a….

Moderate
severity level: 608 units
affected scope: Class II
classification: May 15, 2013
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1277-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-1277-2013
Date reported	May 15, 2013
Date initiated	November 10, 2009
Recalling firm	Olympus America Inc.
Firm location	Center Valley, PA
Affected scope	608
Distribution	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, WA, WV, and WY.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

608 units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1277-2013) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on May 15, 2013. Severity: Moderate. Recall number: Z-1277-2013.

Where was the recalled product distributed? ▼

Distribution: 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, WA, WV, and WY..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

Optimus Recalls Portable Electric Heaters… 2013-05-15 Diazepam Injection, USP 5 mg/mL, 10 mL, M… 2013-05-15 Furosemide Injection, USP, 40 mg/4mL (10 … 2013-05-15 QUELICIN (succinylcholine chloride) Injec… 2013-05-15

Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

Presource PBDS, Gyn Laparoscopy Kit, Circ… 2013-05-15 A) Presource PBDS, Lap Chole, Kit, Clean … 2013-05-15 Presource PBDS, General Laparoscopy, Kit,… 2013-05-15 Presource PBDS, Major Abdominal, Kit, Cir… 2013-05-15

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported May 15, 2013. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026