Force FXRecalls & reported problems across all models

We found 7 models of Force FX by Covidien LP in the FDA's device registry (GUDID). Together they are named in 576 adverse event reports in the FDA's MAUDE database, received between Apr 11, 2017 and May 29, 2026 — classified as 44 injuries, 532 malfunctions.

The most frequently reported specific device problem is “Inaccurate Delivery” (120 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

Most reported Force FX problems

Force FX models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Force FX FORCEFX8C

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  258 reports
• Force FX Force FX-8CS

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  100 reports
• Force FX Force FX-CS

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  89 reports
• FORCE FX FORCEFXC

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  85 reports
• Force FX Force FX-8CAS

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  41 reports
• Force FX Force FX-CS

  Electrosurgical, cutting & coagulation & accessories
  2 reports
• Force FX Force FX-C ZE

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  1 report

Recent Force FX adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2026Failure to Calibrate; Arcing; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT, DURING HEMORRHOID SURGERY, THE GENERATOR HAD SUDDENLY EMITTED A LARGE SPARK, RESULTING IN A BURN TO THE PATIENT¿S NORMAL SKIN TISSUE. AFTER THE EVENT OCCURRED, MEDICAL STAFF IMMEDIATELY TERMINATED THE PROCEDURE AND PROVIDED EMERGENCY TREATMENT TO THE BURNED AREA AND FOLLOWED BY MEDICAL OBSERVATIONS. PRELIMINARY ACTION WAS THE DEVICE WAS SENT FOR THIRD-PARTY TESTING, DURING WHICH IT FAILED TO PASS INSPECTION AND DISPLAYED ERROR CODE 161. THE DEVICE WAS TAKEN OUT OF SERVICE, AND THE MANUFACTURER WAS REQUESTED TO PERFORM FURTHER INSPECTION AND REPAIR.

  Patient problems: Burn(s)

  MAUDE report 25332421 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING MASTECTOMY PROCEDURE, THE TWO UNITS THAT WERE USED AT THE SAME TIME NEEDED AN EVALUATION. PATIENT HAD BRADY HEART RATE. ATROPINE, CHEST COMPRESSIONS (LESS THAN 5 MINUTES) AND EPINEPHRINE WERE REQUIRED TO CORRECT THE BRADYCARDIA. PATIENT HOSPITALIZATION WAS ALSO PROLONGED FOR CARDIAC WORK-UP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arrhythmia

  MAUDE report 25017388 ↗
• MalfunctionMar 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BURN.

  Patient problems: Burn(s)

  MAUDE report 24671586 ↗
• MalfunctionMar 18, 2026Connection Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RIGHT-SIDED RADICAL MASTECTOMY, A NON-MEDTRONIC ABLATION ELECTRODE WAS CONNECTED TO THE HIGH-FREQUENCY ELECTROSURGICAL UNIT, THE CHIEF SURGEON REQUESTED THAT THE ABLATION ELECTRODE BE SWITCHED FROM HAND CONTROL TO FOOT CONTROL. WHILE REMOVING THE CONVERTER PLUG, THE CIRCULATING NURSE'S LEFT INDEX FINGER WAS BURNED, WITH A BLISTER OBSERVED LOCALLY. IMMEDIATE ICE APPLICATION WAS GIVEN. THE SURGERY WITH THE PATIENT WAS COMPLETED SUCCESSFULLY. PHOTO RECEIVED SHOWED THAT THE MONOPOLAR PORT 1 WAS UTILIZED.

  Patient problems: Burn(s)

  MAUDE report 24630621 ↗
• MalfunctionFeb 15, 2026Self-Activation or Keying; Connection Problem

  IT WAS REPORTED THAT DURING THYROIDECTOMY, THE BIPOLAR ELECTROCAUTERY CONTINUED TO FIRE OUT. INVESTIGATION REVEALED THAT THE BIPOLAR FOOT PEDAL FAILED TO RETURN PROPERLY. AN ENGINEER WAS CONTACTED FOR REPAIRS AND THE ISSUE AFFECTED THE SURGICAL PROCEDURE. AFTER THE ENGINEER REPLACED THE BIPOLAR FOOT PEDAL THE EQUIPMENT FUNCTIONED NORMALLY.

  Patient problems: Insufficient Information

  MAUDE report 24341685 ↗
• MalfunctionJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING THE PROCEDURE, THE DEVICE¿S TIP IGNITED (MATCH-SIZED FLAME) DURING USE. THE FLAME SELF-EXTINGUISHED AFTER ACTIVATION WAS STOPPED. NO OPERATING ROOM FIRE WAS REPORTED. FOLLOWING THE INITIAL INCIDENT, THE BIOMED DEPARTMENT CONDUCTED TESTING ON THE ESU AND IDENTIFIED HIGH-VOLTAGE ISSUES WITH THE GENERATOR. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23990348 ↗
• MalfunctionJan 6, 2026Energy Output Problem; Connection Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC SEPTOPLASTY UNDER GENERAL ANESTHESIA FOR A NASAL SEPTUM DEVIATION, THE SURGEON ATTEMPTED BIPOLAR ELECTROCAUTERY FOR HEMOSTASIS, BUT THERE WAS NO RESPONSE FROM THE ELECTROCAUTERY FOOT PEDAL AFTER EXCISION OF THE DEVIATED CARTILAGE. IMMEDIATE COTTON PAD COMPRESSION WAS USED FOR HEMOSTASIS, BUT THE SURGERY COULD NOT PROCEED NORMALLY AND UNABLE TO STOP THE BLEEDING. THE SURGEON PAUSED THE OPERATION AND WAITED, RESTARTING THE DEVICE DID NOT RESOLVE THE ISSUE. EMERGENCY COORDINATION WAS UNDERTAKEN TO REPLACE THE DEVICE AND COMPLETE THE SURGERY, AND THE EQUIPMENT DEPARTMENT WAS NOTIFIED FOR TIMELY REPAIR. THIS EVENT NOT ONLY AFFECTED THE PROGRESS OF THE OPERATION BUT ALSO PROLONGED THE DURATION OF ANESTHESIA.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23973416 ↗
• MalfunctionNov 4, 2025Failure to Deliver Energy; Failure to Calibrate; Connection Problem; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Failure to Calibrate; Connection Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A REMOVAL OF THE GALLBLADDER ON A GANGRENOUS CHOLECYSTECTOMY, THERE WAS ELECTRIC LEAKAGE AT THE WORKING END OF THE BIPOLAR COAGULATION FORCEPS, RESULTING IN DAMAGE TO THE SURROUNDING NORMAL LIVER TISSUE. THE SURGERY WAS IMMEDIATELY PAUSED FOR INSPECTION, WHICH REVEALED A MALFUNCTION IN THE OUTPUT OF THE HIGH-FREQUENCY ELECTROSURGICAL GENERATOR. ANOTHER HIGH-FREQUENCY ELECTROSURGICAL GENERATOR WAS PROMPTLY CONNECTED TO THE BIPOLAR COAGULATION FORCEPS TO CONTINUE THE OPERATION, WHILE MONITORING CHANGES IN THE LIVER TISSUE. SINCE NO MEDICATION OR OTHER INTERVENTION WAS APPLIED TO THE DAMAGED LIVER TISSUE, THE NURSE WAS INSTRUCTED TO CLOSELY OBSERVE THE PATIENT AFTER SURGERY.

  Patient problems: Tissue Breakdown

  MAUDE report 23465578 ↗
• MalfunctionOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A C-SECTION, THE FELLOW WAS USING THE BOVIE PENCIL AND WAS STARTING TO GO THROUGH THE PATIENT'S FASCIA WHILE THE SURGEON WAS HOLDING THE SKIN BACK. THE SURGEON WAS ON THE RIGHT SIDE OF THE PATIENT AS WELL AS THE GROUNDING PAD WHICH WAS PLACED ON THE RIGHT THIGH, AND THE GENERATOR WAS ALSO ON THE RIGHT SIDE. THE POWER ON THE FX WAS AT 35/35. THE SURGEON SAID THERE WAS A HOLE IN HER GLOVE AND SHE WAS DOUBLE GLOVED. THE SURGEON FELT HEAT AND A LITTLE JOLT. THE SURGEON FELT A PAIN THAT WENT UP HER RIGHT ARM AND ACROSS HER CHEST TO HER HEART. THE SURGEON REPORTED TO FEEL NOT RIGHT AND HER HEART STARTED TO RACE. THE SURGEON BACKED AWAY FROM THE TABLE AND THEY HAD TO CALL CODE BLUE, HOWEVER, THE SURGEON WAS ABLE TO AMBULATE OUT OF THE OPERATING ROOM INDEPENDENTLY, AND RESUSCITATION WAS NOT REQUIRED. A NEW GENERATOR AND BOVIE PENCIL WAS OPENED TO COMPLETE THE PROCEDURE. THE PATIENT AND THE BABY WAS NOT HARMED/INJURED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Electric Shock; Tachycardia

  MAUDE report 23367536 ↗
• MalfunctionOct 21, 2025Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT DURING A PROCEDURE, UNIT'S REM WAS ABNORMAL. THE REM SIGNAL REMAINED GREEN WHEN IT SHOULD NOT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23345121 ↗
• InjuryOct 15, 2025Failure to Calibrate; Failure to Align; Adverse Event Without Identified Device or Use Problem; Failure to Calibrate; Failure to Align; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE TEMPLE BIOPSY, THE PATIENT WAS UNDER PARTIAL SEDATION. THE STAFF STARTED OFF WITH A CANNULA, THEN MOVED TO AN OXYGEN MASK. AFTER CHANGING TO THE MASK, THE DRAPE COVERING THE PATIENT, AS WELL AS THE MASK, CAUGHT ON FIRE. THE PATIENT WAS BURNT AND MASK THAT THE PATIENT WAS WEARING. THE DRAPE WAS THROWN TO THE FLOOR TO PREVENT ANY FURTHER INJURY. THE PATIENT WAS STABLE AFTER THE INCIDENT AND WAS CURRENTLY AT ANOTHER FACILITY RECOVERING FROM INJURIES SUSTAINED FROM THE BURNS. IT WAS PRESUMED THAT WHEN THE HANDPIECE WAS USED WITH THE OXYGEN MASK, IT MIGHT HAVE, CREATED AN OXYGEN RICH ENVIRONMENT, CAUSING THE FIRE. THE BIOMED PERFORMED OUTPUT TESTING USING TEST CABLES AND FOUND THAT ALL OUT FOR CUT, COAGULATION AND BIPOLAR WERE WITHIN SPECIFICATION. THE CUT WAS TESTED AT WATTAGE OF 75, COAGULATION AT A WATTAGE OF 30 AND BIPOLAR AT A WATTAGE OF 10. NO ISSUES FOUND. THE ONLY ISSUE BIOMED FOUND WAS DURING TESTING OF REM (RETURN ELECTRODE MONITOR) AT 135 OHMS--INSTEAD OF GETTING A VALUE OF 135 PLUS MINUS 5. THE BIOMED WAS GETTING A VALUE OF 143 OHMS WHICH IS 3 POINTS HIGHER THAN SPECIFICATION. THE PATIENT SUFFERED INJURIES FROM BURNS.

  Patient problems: Burn(s)

  MAUDE report 23292304 ↗
• MalfunctionSep 19, 2025Inaccurate Delivery; Failure to Calibrate; Inaccurate Delivery; Failure to Calibrate

  IT WAS REPORTED THAT PRIOR TO USE, UNIT WAS FAILING THE HIGH-RESISTANCE TEST (>135 OHMS). IT WAS ONLY TRIGGERING THE LOW-RESISTANCE ALARM. CONFIRMED THE OSCILLATOR WAS FUNCTIONING AT 82KHZ AND RE-CALIBRATED REM CALIBRATION VALUES. IT STILL DID NOT ALARM WHEN ADDED RESISTANCE WITH THE DECADE BOX. TRIED A DIFFERENT DECADE BOX AND CONFIRMED BOTH WERE PROPERLY FUNCTIONING WITH A MULTIMETER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23093077 ↗
• MalfunctionJul 22, 2025Connection Problem; Electrical Shorting; Adverse Event Without Identified Device or Use Problem; Connection Problem; Electrical Shorting; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, AN INCIDENT OCCURRED WITH THE NON-MEDTRONIC MONOPOLAR CABLE. THIS SHORT-CIRCUITED THE CABLE, FRACTURING IT AND CAUSING A MINOR BURN TO PART OF THE DOCTOR'S SURGICAL GOWN AND THE PATIENT HAD A BURN IN THE SKIN.

  Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563080 ↗
• MalfunctionJul 10, 2025Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT THE UNIT WAS CUTTING WHEN IT WAS SUPPOSED TO BE COAGULATING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22467436 ↗
• MalfunctionJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A BURN OCCURRED IN A PATIENT.

  Patient problems: Burn(s)

  MAUDE report 22465184 ↗

Other Covidien LP products

• Endo GIA48 models · 26,277 reports · 8 recalls
• Endo GIA Ultra3 models · 15,650 reports
• Shiley387 models · 9,392 reports · 5 recalls
• Signia16 models · 8,201 reports · 6 recalls
• LigaSure32 models · 7,283 reports · 1 recall
• Tri-Staple 2.037 models · 4,892 reports · 2 recalls
• Polysorb291 models · 4,564 reports · 2 recalls
• EEA39 models · 4,432 reports · 1 recall