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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64935

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
November 10, 2009
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Olympus America Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1277-2013
Recall number
Z-1277-2013
Initiated
November 10, 2009
Classification
Class II
Status
Terminated
Recalling firm
Olympus America Inc.
Quantity
608

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

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Inspect official wording and provenance

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

Code information

Model UES-40, all serial numbers prior to 7925334 that have not been upgraded.

Distribution pattern

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.