FDA Medical Device Recalls (openFDA)
ConMed Electrosurgery: ConMed System 2450 Electrosurgical Generator, REF 60-2450-120-69, 120V, (Refurbished), ConMed Electrosurgery, Centennial, CO. A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site.
- Recall number
- Z-1366-2011
- Recalling firm
- ConMed Electrosurgery
- Product
- ConMed System 2450 Electrosurgical Generator, REF 60-2450-120-69, 120V, (Refurbished), ConMed Electrosurgery, Centennial, CO. A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site.
- Status
- Terminated
- Initiated
- 2010-12-27
- Posted
- 2011-02-17
- Terminated
- 2011-08-01
- Reason
- Electrosurgical generator may allow possibility of electrical shock and/or burns to user or patient.
- Root cause
- Device Design
- Action
- ConMed Electrosurgery sent an Urgent Device Recall letter dted December 27, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify anyone who may have received the affected product.. They were to review their inventory and return a Business Reply Form via fax to 303-699-9854 and to contact ConMed Electrosurgery Technical Services at 800-552-0138 to schedule a time to have their equipment upgraded.
- Quantity
- 29 units
- Distribution
- Worldwide Distribution, including USA (nationwide) and the countries of Australia, Belgium, Bolivia, Canada, Chile, China, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Honduras, Hong Kong, Hungary, India, Iraq, Israel, Italy, Jamaica, Japan, Jordan, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela, Vietnam.
- Lot, serial or model codes
- Serial numbers: 05KGU008, 05KGU012, 06BGU004, 06BGU011, 06BGU013, 06BGU016, 06BGU025, 06DGU005, 06DGU015, 06DGU038, 06EGU026, 06EGU027, 06EGU035, 06EGU105, 06EGU106, 06EGU142, 06FGU008, 06FGU014, 06FGU067, 06GGU015, 06GGU057, 06JGU047, 07DGU031, 07DGU036, 07DGU037, 07DGU041, 08CGU061, 08CGU062, 08CGU073.
- 510(k) numbers
- ["K052009"]
- 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