Conmed Electrosurgery

Country not established

Devices: 1
FDA recalls: 34

At a glance

Counted by deviCERTS from registry records

Market reach

United States: FDA recalls

What Conmed Electrosurgery makes

Conmed Electrosurgery manufactures electrosurgical units, including the SYSTEM 7500-B, designed for surgical procedures. Their portfolio includes specialized probes like the ABCFLEX for flexible endoscopy, intended for precision cutting and coagulation in minimally invasive surgeries.

These devices are classified as Class II under FDA regulations and are listed in the 510(k) clearance registry. The company operates from the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

System 7500-B Electrosurgical Unit; Abcflex Probe For Flexible Endoscopy Ref K050161

Active Regimes: 510(k) Registry: 510(k) Class:II

FDA recalls34

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 34 recalls initiated by Conmed Electrosurgery, the earliest on 2003-09-15 and the most recent on 2012-05-07. By recorded status: 34 terminated. The reasons filed fall into these groups: sterility or contamination, packaging, electrical or power, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Showing the 10 most recent of 34 recalls.

2012
- 7 May 2012 Z-1678-2012 Not yet classified Terminated An investigation of the ConMed Electrosurgery Altrus Energy Source revealed that the device could have been calibrated incorrectly resulting in error messages or delays in surgery. Distribution: Nationwide Distribution and the country of Canada. Submission number: K101534
- 7 May 2012 Z-1679-2012 Not yet classified Terminated The devices were distributed prior to the firm completing performance qualifications for their package sealing and adhesive bonding. Distribution: Class II Recall-Nationwide Distribution-including the states of OH, GA, IL, PA, AZ, KY, FL, NY, MO, TN, TX, AL, IN, SC,…
  Full distribution text
  Class II Recall-Nationwide Distribution-including the states of OH, GA, IL, PA, AZ, KY, FL, NY, MO, TN, TX, AL, IN, SC, MD, CT, NJ, and CA.
  Submission number: K101534
- 7 May 2012 Z-1680-2012 Not yet classified Terminated The devices were distributed prior to the firm completing performance qualifications for their package sealing and adhesive bonding. Distribution: Class II Recall-Nationwide Distribution-including the states of OH, GA, IL, PA, AZ, KY, FL, NY, MO, TN, TX, AL, IN, SC,…
  Full distribution text
  Class II Recall-Nationwide Distribution-including the states of OH, GA, IL, PA, AZ, KY, FL, NY, MO, TN, TX, AL, IN, SC, MD, CT, NJ, and CA.
  Submission number: K101534
- 7 May 2012 Z-1681-2012 Not yet classified Terminated The devices were distributed prior to the firm completing performance qualifications for their package sealing and adhesive bonding. Distribution: Class II Recall-Nationwide Distribution-including the states of OH, GA, IL, PA, AZ, KY, FL, NY, MO, TN, TX, AL, IN, SC,…
  Full distribution text
  Class II Recall-Nationwide Distribution-including the states of OH, GA, IL, PA, AZ, KY, FL, NY, MO, TN, TX, AL, IN, SC, MD, CT, NJ, and CA.
  Submission number: K101534
- 7 May 2012 Z-1682-2012 Not yet classified Terminated The devices were distributed prior to the firm completing performance qualifications for their package sealing and adhesive bonding. Distribution: Class II Recall-Nationwide Distribution-including the states of OH, GA, IL, PA, AZ, KY, FL, NY, MO, TN, TX, AL, IN, SC,…
  Full distribution text
  Class II Recall-Nationwide Distribution-including the states of OH, GA, IL, PA, AZ, KY, FL, NY, MO, TN, TX, AL, IN, SC, MD, CT, NJ, and CA.
  Submission number: K101534
2010
- 27 Dec 2010 Z-1362-2011 Unclassified (pre-2012) Terminated Electrosurgical generator may allow possibility of electrical shock and/or burns to user or patient. Distribution: Worldwide Distribution, including USA (nationwide) and the countries of Australia, Belgium, Bolivia, Canada, Chile,…
  Full distribution text
  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.
  Submission number: K052009
- 27 Dec 2010 Z-1363-2011 Unclassified (pre-2012) Terminated Electrosurgical generator may allow possibility of electrical shock and/or burns to user or patient. Distribution: Worldwide Distribution, including USA (nationwide) and the countries of Australia, Belgium, Bolivia, Canada, Chile,…
  Full distribution text
  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.
  Submission number: K052009
- 27 Dec 2010 Z-1364-2011 Unclassified (pre-2012) Terminated Electrosurgical generator may allow possibility of electrical shock and/or burns to user or patient. Distribution: Worldwide Distribution, including USA (nationwide) and the countries of Australia, Belgium, Bolivia, Canada, Chile,…
  Full distribution text
  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.
  Submission number: K052009
- 27 Dec 2010 Z-1365-2011 Unclassified (pre-2012) Terminated Electrosurgical generator may allow possibility of electrical shock and/or burns to user or patient. Distribution: Worldwide Distribution, including USA (nationwide) and the countries of Australia, Belgium, Bolivia, Canada, Chile,…
  Full distribution text
  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.
  Submission number: K052009
- 27 Dec 2010 Z-1366-2011 Unclassified (pre-2012) Terminated Electrosurgical generator may allow possibility of electrical shock and/or burns to user or patient. Distribution: Worldwide Distribution, including USA (nationwide) and the countries of Australia, Belgium, Bolivia, Canada, Chile,…
  Full distribution text
  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.
  Submission number: K052009

Show the 25 most recent of 34 recalls

2010
- 29 Mar 2010 Z-1562-2010 Unclassified (pre-2012) Terminated Electrosurgical pencil may remain activated or self activate after power switch is released. Distribution: Nationwide, including 2 VA facilities in GA and 1 military facility in UT. Foreign distribution to Australia, Belgium,…
  Full distribution text
  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.
  Submission number: K791137
- 29 Mar 2010 Z-1563-2010 Unclassified (pre-2012) Terminated Electrosurgical pencil may remain activated or self activate after power switch is released. Distribution: Nationwide, including 2 VA facilities in GA and 1 military facility in UT. Foreign distribution to Australia, Belgium,…
  Full distribution text
  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.
  Submission number: K791137
- 29 Mar 2010 Z-1564-2010 Unclassified (pre-2012) Terminated Electrosurgical pencil may remain activated or self activate after power switch is released. Distribution: Nationwide, including 2 VA facilities in GA and 1 military facility in UT. Foreign distribution to Australia, Belgium,…
  Full distribution text
  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.
  Submission number: K791137
- 29 Mar 2010 Z-1565-2010 Unclassified (pre-2012) Terminated Electrosurgical pencil may remain activated or self activate after power switch is released. Distribution: Nationwide, including 2 VA facilities in GA and 1 military facility in UT. Foreign distribution to Australia, Belgium,…
  Full distribution text
  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.
  Submission number: K791137
- 29 Mar 2010 Z-1566-2010 Unclassified (pre-2012) Terminated Electrosurgical pencil may remain activated or self activate after power switch is released. Distribution: Nationwide, including 2 VA facilities in GA and 1 military facility in UT. Foreign distribution to Australia, Belgium,…
  Full distribution text
  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.
  Submission number: K791137
- 29 Mar 2010 Z-1567-2010 Unclassified (pre-2012) Terminated Electrosurgical pencil may remain activated or self activate after power switch is released. Distribution: Nationwide, including 2 VA facilities in GA and 1 military facility in UT. Foreign distribution to Australia, Belgium,…
  Full distribution text
  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.
  Submission number: K791137
- 29 Mar 2010 Z-1568-2010 Unclassified (pre-2012) Terminated Electrosurgical pencil may remain activated or self activate after power switch is released. Distribution: Nationwide, including 2 VA facilities in GA and 1 military facility in UT. Foreign distribution to Australia, Belgium,…
  Full distribution text
  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.
  Submission number: K791137
- 29 Mar 2010 Z-1569-2010 Unclassified (pre-2012) Terminated Electrosurgical pencil may remain activated or self activate after power switch is released. Distribution: Nationwide, including 2 VA facilities in GA and 1 military facility in UT. Foreign distribution to Australia, Belgium,…
  Full distribution text
  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.
  Submission number: K791137
- 29 Mar 2010 Z-1570-2010 Unclassified (pre-2012) Terminated Electrosurgical pencil may remain activated or self activate after power switch is released. Distribution: Nationwide, including 2 VA facilities in GA and 1 military facility in UT. Foreign distribution to Australia, Belgium,…
  Full distribution text
  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.
  Submission number: K791137
- 29 Mar 2010 Z-1571-2010 Unclassified (pre-2012) Terminated Electrosurgical pencil may remain activated or self activate after power switch is released. Distribution: Nationwide, including 2 VA facilities in GA and 1 military facility in UT. Foreign distribution to Australia, Belgium,…
  Full distribution text
  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.
  Submission number: K791137
- 29 Mar 2010 Z-1572-2010 Unclassified (pre-2012) Terminated Electrosurgical pencil may remain activated or self activate after power switch is released. Distribution: Nationwide, including 2 VA facilities in GA and 1 military facility in UT. Foreign distribution to Australia, Belgium,…
  Full distribution text
  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.
  Submission number: K791137
- 29 Mar 2010 Z-1573-2010 Unclassified (pre-2012) Terminated Electrosurgical pencil may remain activated or self activate after power switch is released. Distribution: Nationwide, including 2 VA facilities in GA and 1 military facility in UT. Foreign distribution to Australia, Belgium,…
  Full distribution text
  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.
  Submission number: K791137
2009
- 30 Sep 2009 Z-0165-2010 Unclassified (pre-2012) Terminated One production lot of Suction Coagulators received ETO sterilization instead of gamma radiation sterilization. Distribution: US only. CA, FL, GA, ID, IL, IN, KY, LA, MD, MI, MO, MS, NC, NY, OH, OR, PA, SC, SD, TX, VA Submission number: K052104
2008
- 18 Dec 2008 Z-2276-2010 Unclassified (pre-2012) Terminated The internal electrode protrudes in front of the ceramic insulator at the tip of the handpiece. Distribution: Nationwide and International Submission number: K961505
- 18 Dec 2008 Z-2277-2010 Unclassified (pre-2012) Terminated The internal electrode protrudes in front of the ceramic insulator tip of the handpiece. Distribution: Nationwide and International Submission number: K961505

Frequently asked questions

How many devices does Conmed Electrosurgery have in the registry?

The registry currently lists 1 device for Conmed Electrosurgery. Devices recorded under merged duplicate company entries are counted once.

Which registries list Conmed Electrosurgery's devices?

Among its 1 most recently registered device, Conmed Electrosurgery has devices listed in FDA 510(k) (1 device).

What risk classes do Conmed Electrosurgery's devices fall under?

Among its 1 most recently registered device, the classes recorded for Conmed Electrosurgery's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Conmed Electrosurgery?

FDA recall records list 34 recalls initiated by Conmed Electrosurgery, the most recent initiated on 7 May 2012. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Conmed Electrosurgery in the registry?

The most recently registered devices listed for Conmed Electrosurgery include SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY.

Generated automatically from registry data and not verified by a human reviewer.