UltraCleanRecalls & reported problems across all models
Conmed Corporation · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 84
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 8 models of UltraClean by Conmed Corporation in the FDA's device registry (GUDID). Together they are named in 84 adverse event reports in the FDA's MAUDE database, received between Feb 4, 2016 and Jun 11, 2026 — classified as 3 injuries, 81 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (60 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported UltraClean problems
Device problems
- Delivered as Unsterile Product60
- Material Fragmentation6
- Packaging Problem5
- Device Packaging Compromised2
- Fire2
- Sparking2
- Device Operates Differently Than Expected1
- Flare or Flash1
Patient problems
- No Clinical Signs, Symptoms or Conditions61
- No Patient Involvement11
- No Known Impact Or Consequence To Patient4
- No Consequences Or Impact To Patient3
- Burn(s)2
- Foreign Body In Patient2
- Patient Problem/Medical Problem1
- Superficial (First Degree) Burn1
UltraClean models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- UltraClean 139112EXTELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES39 reports
- UltraClean 139105EXTELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES19 reports
- UltraClean 139110EXTELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES13 reports
- UltraClean 139112ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES6 reports
- UltraClean 139104EXTELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES3 reports
- ULTRACLEAN 139112EXTELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- ULTRACLEAN 139110EXTELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- ULTRACLEAN 139105EXTELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
Recent UltraClean adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2026Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 139112EXT, 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 25470127 ↗MalfunctionJun 11, 2026Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 139112EXT, 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 25470123 ↗MalfunctionMar 9, 2026Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 139112EXT, 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 24548096 ↗MalfunctionMar 9, 2026Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 139112EXT, 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 24547918 ↗MalfunctionMar 9, 2026Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 139112EXT, 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 24546292 ↗MalfunctionMar 3, 2026Material Fragmentation; Melted
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 139112, ULTRACLEAN ACCESSORY ELECTRODE 4" (10.16 CM) COATED BLADE, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2026 WHEN IT WAS REPORTED, ¿DURING A PROCEDURE WITH A LOT OF CAUTERY THE 4 INCH GUARDED TIP SECTION APPEARED TO MELT ENOUGH TO THE POINT WHERE THE GUARDED SECTION AND THE GREY STABILITY HOLDER CAME APART FROM THE ACTUAL BLADE.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT WAS REQUESTED AND FOUND THAT THERE WAS FRAGMENTATION THAT FELL INTO THE SURGICAL SITE. THE FRAGMENTATION WAS RETRIEVED USING FORCEPS. 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 24494751 ↗MalfunctionDec 17, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
THE DISTRIBUTOR REPORTED THAT THE 139112EXT DEVICE HAD AN INSUFFICIENT HEATSEAL FOUND DURING INCOMING INSPECTION. NO PATIENT INVOLVEMENT OCCURRED. 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 23830552 ↗MalfunctionSep 18, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 139105EXT, 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 23082570 ↗MalfunctionJul 10, 2025Sparking; Sparking
THE CUSTOMER REPORTED THAT THE DEVICE, 139110EXT, ACCESSORY ELECTRODE COATED BLADE W/EXTENDED INSULATION WAS BEING USED ON (B)(6) 2025 AND ¿WHILE CAUTERIZING, THE DOCTOR EXPERIENCED A SPARK THROUGH THE DISTAL, INSULATED PORTION OF THE 6¿ COATED BLADE WITH EXTENDED INSULATION BOVIE TIP WHICH CAUSED A SUPERFICIAL THERMAL INJURY TO THE PATIENT.¿ THE PROCEDURE WAS COMPLETED WITH A MEGADINE BOVIE TIP AND THERE WAS A 2-HOUR DELAY. THERE WAS NO REPORT OF MEDICAL/SURGICAL INTERVENTION OR PROLONGED HOSPITALIZATION FOR THE PATIENT. A GOOD FAITH EFFORT WAS COMPLETED TO OBTAIN MORE INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: Superficial (First Degree) Burn
MAUDE report 22469549 ↗InjuryJun 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE 139110EXT, ACCESSORY ELECTRODE COATED BLADE W/EXTENDED INSULATION DEVICE WAS USED IN AN UNNAMED PROCEDURE ON APPROXIMATELY ON (B)(6) 2025, AND "THIS BOVIE BURNT THE PATIENT UNDER DOCTORS USE." FURTHER ASSESSMENT WAS ATTEMPTED, AND A GOOD FAITH EFFORT WAS MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF A BURN OF UNKNOWN DEGREE TO THE PATIENT.
Patient problems: Burn(s)
MAUDE report 22174672 ↗InjuryApr 30, 2025Material Fragmentation; Material Fragmentation
CONMED JAPAN REPORTED ON BEHALF OF THE CUSTOMER THAT THE 139105EXT, ACCESSORY ELECTRODE COATED NEEDLE WAS BEING USED ON (B)(6) 2025 DURING A RESECTION OF HEAD TUMOR PROCEDURE WHEN IT WAS REPORTED ¿A PHYSICIAN WAS USING A 139105EXT AND CLOSED THE WOUND ON A PATIENT WITHOUT NOTICING THAT THE TIP WAS BROKEN. AFTER CLOSING THE WOUND, HE DISCOVERED THAT THE TIP OF THE PRODUCT WAS BROKEN. AFTER THE SURGERY, AN X-RAY WAS PERFORMED, BUT THE TIP COULD NOT BE FOUND. THE SURGERY WAS COMPLETED WITHOUT FINDING IT, AND THE PATIENT WAS INFORMED THAT THERE WAS A POSSIBILITY THAT THE PRODUCT WAS LEFT BEHIND.¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON REPORTED INJURY DUE TO THE POSSIBILITY OF THE PATIENT RETAINING A FOREIGN BODY.
Patient problems: Foreign Body In Patient
MAUDE report 21933479 ↗MalfunctionApr 25, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 139112EXT, 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 21908617 ↗MalfunctionFeb 25, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
UPDATE: THE DEVICE WAS RETURNED AND EVALUATED. THE COMPLETION OF THE DEVICE EVALUATION CONFIRMED AN INSUFFICIENT HEATSEAL; THEREFORE, THIS COMPLAINT HAS BEEN REASSESSED AND MEETS THE CRITERIA FOR A REPORTABLE EVENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE. THE DISTRIBUTOR REPORTED THAT THE 139112EXT DEVICE HAD AN INSUFFICIENT HEATSEAL FOUND DURING INCOMING INSPECTION. NO PATIENT INVOLVEMENT OCCURRED. THE SHIPMENT ASSOCIATED WITH THE RGA FOR THIS DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION AND IT HAS NOT BEEN CONFIRMED THAT AN INSUFFICIENT HEATSEAL CAUSING A STERILITY BREACH HAS OCCURRED. BASED ON THE INFORMATION AVAILABLE, AND THE DECISION TREE RESULTS, THIS COMPLAINT DOES NOT MEET THE DEFINITION OF A REPORTABLE EVENT. UPON THE RECEIPT OF THE DEVICE, AN EVALUATION WILL BE CONDUCTED AND IF A BREACH OF STERILITY IS CONFIRMED THE REPORTING DECISION WILL BE REASSESSED AT THAT TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21459387 ↗MalfunctionJan 22, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 139104EXT ACCESSORY ELECTRODE COATED BLADE WITH EXTENDED INSULATION, 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 21207564 ↗MalfunctionDec 27, 2024Material Fragmentation; Sparking; Material Fragmentation; Sparking
THE CUSTOMER REPORTED THAT THE 139105EXT, ACCESSORY ELECTRODE COATED NEEDLE WITH EXTENDED INSULATION, DEVICE WAS BEING USED IN AN UNKNOWN PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿THE ELECTRODE STARTED SPARKING AND THEN THE PLASTIC COVERING FELL OFF SPLITTING INSIDE THE PATIENT.". FURTHER ASSESSMENT WAS ATTEMPTED, AND A GOOD FAITH EFFORT WAS COMPLETED BUT TO DATE NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. UPDATE: THE CUSTOMER CONFIRMED THAT THIS EVENT OCCURRED DURING A BREAST PROCEDURE AND THE FRAGMENT WAS RETRIEVED FROM THE PATIENT BY HAND. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 21025687 ↗
Other Conmed Corporation products
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- VCARE4 models · 285 reports
- PlumePen8 models · 132 reports
- CONMED GOLDLINE10 models · 112 reports
- ANCHOR TISSUE RETRIEVAL SYSTEM8 models · 92 reports
- UNIVERSAL PLUS9 models · 68 reports
- Y-KNOT14 models · 65 reports
- GENESYS CrossFT, Hi-Fi4 models · 4 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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