CONMED 138110Recalls & reported problems
Conmed Corporation · CONMED Accessory Electrode, 6 Inch (15.24 cm) Flat Blade with Extended Insulation · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Conmed flat blade electrosurgical electrode is used for cutting and coagulating tissue during surgery. The 27 reports mostly describe units arriving not fully sealed or not sterile, which distributors caught during incoming inspection before any patient contact. There are no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 30653405003452), received between Feb 26, 2018 and Mar 12, 2026 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (25 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Delivered as Unsterile Product25
- Packaging Problem1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- No Patient Involvement2
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 12, 2026Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138110, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. DUE TO THE POTENTIAL SEVERITY OF A BREACH IN STERILITY, THIS COMPLAINT MEETS THE CRITERIA FOR A REPORTABLE EVENT. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24578307 ↗MalfunctionSep 12, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138110, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23037079 ↗MalfunctionDec 5, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138110, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20852568 ↗MalfunctionSep 5, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138110, ELEC,BLDE,LNG,EXT,INSULATD,40, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20143883 ↗MalfunctionJul 15, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138110, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19740242 ↗MalfunctionMay 1, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138110, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19220405 ↗MalfunctionJan 24, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138110, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18571841 ↗MalfunctionJan 22, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138110, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. PERFORMED A FUNCTIONAL INSPECTION, THE DEVICES WERE DYE LEAK TESTED WHICH INDICATED THAT THE PACKAGING HAD AN INSUFFICIENT HEAT SEAL. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18551460 ↗MalfunctionOct 23, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138110, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17983863 ↗MalfunctionSep 12, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138110, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17730589 ↗MalfunctionJun 1, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138110, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17038560 ↗MalfunctionJun 1, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138110, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17037706 ↗MalfunctionApr 28, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138110, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16831668 ↗MalfunctionMar 9, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE,138110, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16511592 ↗MalfunctionJan 27, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE 138110, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16254283 ↗MalfunctionJan 20, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE,138110, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16216301 ↗MalfunctionAug 22, 2022Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138110, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15266598 ↗MalfunctionJul 21, 2022Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138110, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15076733 ↗MalfunctionJun 24, 2022Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138110, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14804690 ↗MalfunctionApr 25, 2022Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138110, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14194480 ↗MalfunctionMar 3, 2022Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138110, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13660757 ↗MalfunctionDec 6, 2021Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138110, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12932852 ↗MalfunctionNov 4, 2021Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138110, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12751420 ↗MalfunctionAug 25, 2021Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, CATALOG # 138110, LOT 201910141, FOR A POSSIBLE BREACH OF STERILITY DUE TO AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH ANY PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION IN (B)(6). THE COMPLETION OF THE DEVICE EVALUATION CONFIRMED AN INSUFFICIENT HEATSEAL; THEREFORE, THIS COMPLAINT MEETS THE CRITERIA FOR A REPORTABLE EVENT. DUE TO THE BREACH IN STERILITY, THIS REPORT IS BEING RAISED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12367933 ↗MalfunctionMay 25, 2021Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 6IN FLAT BLADE ELECTRODE,EXTENDED INSULATION, CATALOG # 138110, LOT 201909091, FOR A POSSIBLE BREACH OF STERILITY DUE TO AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH ANY PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION IN (B)(6). THE COMPLETION OF THE DEVICE EVALUATION CONFIRMED AN INSUFFICIENT HEATSEAL. DUE TO THE BREACH IN STERILITY, THIS REPORT IS BEING RAISED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11881890 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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