Z-1563-2010

ConMed Goldline Hand Controlled With Blade Electrode, Tip Cleaner, Rocker Switch, Safety Holster and 10 FT...

Name: Z-1563-2010 ConMed Goldline Hand Controlled With Blade Electrode, Tip Cleaner, Rocker Switch, Safety Holster and 10 FT...
Creator: ConMed Electrosurgery
Published: 2010-03-29
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2010-03-29 / Terminated / root cause: design

FDA source

ConMed Electrosurgery began a recall of ConMed Goldline Hand Controlled With Blade Electrode, Tip Cleaner, Rocker Switch, Safety Holster and 10 FT Cable, REF 130304A, Sterile R, Assembled in Mexico... on 2010-03-29. The reason FDA records is "Electrosurgical pencil may remain activated or self activate after power switch is released". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1563-2010
Status: Terminated
Initiated: 2010-03-29
Posted: 2010-05-10
Terminated: 2010-09-27
Recalling firm: ConMed Corporation
Product: ConMed Goldline Hand Controlled With Blade Electrode, Tip Cleaner, Rocker Switch, Safety Holster and 10 FT Cable, REF 130304A, Sterile R, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, NY 13502.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Electrosurgical pencil may remain activated or self activate after power switch is released.
Root cause tag: design
FDA root cause: Device Design
Action: Customers were notified by letter on March 25, 2010, and were instructed to return all affected devices and to forward the recall information to anyone that may have received the devices to the end user. More information is available by contacting the firm directly at 800-552-0138.
Quantity in commerce: 13,920 units (US), 2,080 units (Foreign)
Distribution: Nationwide, including 2 VA facilities in GA and 1 military facility in UT. Foreign distribution to Australia, Belgium, Canada, China, Dominican Republic, El Salvador, Japan, Korea, Mexico, Puerto Rico, Saudi Arabia, Spain, Taiwan.
Product codes and lots: Lot code range: 0903253 through 1002143

Product code GEI

K791137Class IISingle Use Monopolar Hand Control PencilDavol, Inc. / cleared 1979-07-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)