FDA Medical Device Recalls (openFDA)
ConMed Electrosurgery: 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.
- Recall number
- Z-1563-2010
- Recalling firm
- ConMed Electrosurgery
- 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.
- Status
- Terminated
- Initiated
- 2010-03-29
- Posted
- 2010-05-10
- Terminated
- 2010-09-27
- Reason
- Electrosurgical pencil may remain activated or self activate after power switch is released.
- 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
- 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.
- Lot, serial or model codes
- Lot code range: 0903253 through 1002143
- 510(k) numbers
- ["K791137"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3004491689
- Firm city
- Centennial
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28