Integra DuoRecalls & reported problems across all models
Integra Lifesciences (Ireland) Limited · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 45
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 3 models of Integra Duo by Integra Lifesciences (Ireland) Limited in the FDA's device registry (GUDID). Together they are named in 45 adverse event reports in the FDA's MAUDE database, received between Dec 2, 2021 and May 27, 2026 — classified as 3 injuries, 42 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (31 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 Integra Duo problems
Device problems
- Overheating of Device31
- Electrical Shorting5
- Intermittent Energy Output4
- Adverse Event Without Identified Device or Use Problem3
- Power Problem3
- Battery Problem2
- Insufficient Heating2
- Intermittent Loss of Power2
Patient problems
- No Clinical Signs, Symptoms or Conditions42
- Headache3
- Pain1
Integra Duo models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Integra® Duo 90620USLight, headband, surgical33 reports
- Integra® Duo 90600Light, headband, surgical10 reports
- Integra® Duo 90622Light, headband, surgical2 reports
Recent Integra Duo adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2026Overheating of Device; Power Problem
A FACILITY REPORTED THAT THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) HEADLIGHT FAN WAS NOT COMING ON, CAUSING THE HEADLIGHT TO OVERHEAT AND FLICKER. THERE WAS NO PATIENT INJURY, DEATH, OR SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25301016 ↗MalfunctionMar 23, 2026Overheating of Device
A FACILITY REPORTED THAT THE PRODUCT DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) LIGHT WAS PULSING WHEN IN OPERATION, SIGNIFYING THAT IT WAS PROBABLY OVERHEATING, AS THE FAN ON TOP WAS NOT SPINNING ANYMORE. THERE WAS NO PATIENT INVOLVEMENT, AND NO INJURIES OR SURGICAL DELAYS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24661781 ↗MalfunctionFeb 4, 2026Overheating of Device
A FACILITY REPORTED THAT THE DUO HEADLIGHT AND CARRYING CASE (90600) LAMP BEGAN TO BLINK AND ¿GETS REALLY HOT; THE FAN DOES NOT WORK.¿ NO INJURY, DEATH, OR INCREASE IN SURGICAL TIME WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24257536 ↗MalfunctionNov 28, 2025Overheating of Device; Overheating of Device
A FACILITY REPORTED THAT THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) OVERHEATED AND SHUT OFF DURING A PROCEDURE. IT WAS STATED THAT THE FAN MAY NOT BE FUNCTIONING PROPERLY. NO PATIENT INJURY OR SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23673972 ↗MalfunctionNov 17, 2025Melted; Melted
A FACILITY REPORTED THAT THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) HAD A MELTING MARK ON THE COVER OF THE BAND ADJUSTING GEAR. IN ADDITION, THE CABLE WAS ALMOST PULLED OUT OF THE DEVICE. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE OBSERVED, AND NO DELAY HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23576764 ↗MalfunctionOct 27, 2025Overheating of Device; Intermittent Energy Output; Overheating of Device; Intermittent Energy Output
A FACILITY REPORTED THAT THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) FAN WAS NOT WORKING AND OVERHEATING, MAKING THE LIGHT FLICKER. THERE WAS NO PATIENT INJURY OR SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23393807 ↗MalfunctionOct 27, 2025Overheating of Device; Defective Component; Intermittent Energy Output; Overheating of Device; Defective Component; Intermittent Energy Output
MalfunctionSep 8, 2025Overheating of Device; Overheating of Device
A FACILITY REPORTED THAT DURING SURGERY, THE DUO HEADLIGHT AND CARRYING CASE (90600) WAS OVERHEATING ON THE DOCTOR'S HEAD, AND THE PLASTIC HAD MELTED. IT WAS ALSO REPORTED THAT THE BUTTON FOR CHANGING THE LIGHT SNOB DOES NOT WORK. THE WERE NO REPORTS OF INJURIES, DEATH, OR SURGICAL DELAYS AS ANOTHER "LED DUO" WAS USED TO COMPLETE THE SURGERY. IT WAS NOTED THAT THE SURGEON WAS NOT BURNED BECAUSE THE PHYSICIAN REMOVED THE DEVICE PROMPTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22992997 ↗MalfunctionApr 17, 2025Overheating of Device; Intermittent Energy Output; Overheating of Device; Intermittent Energy Output
IT WAS REPORTED THAT THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) STARTS TO "FLICKER AND GETS PRETTY HOT," AFTER BEING ON FOR A WHILE. IT WAS ALSO REPORTED THAT THE FAN WAS NOT RUNNING, "POSSIBLY OVERHEATING." THE DEVICE WAS NOT IN CONTACT WITH A PATIENT. NO PATIENT INJURY, DEATH, OR SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21854924 ↗MalfunctionFeb 10, 2025Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem
MalfunctionFeb 10, 2025Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem
MalfunctionFeb 5, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) OVERHEATED AND STARTED TO "STROBE" DURING A PROCEDURE. THE DEVICE WAS NOT IN CONTACT WITH THE PATIENT. IT WAS REPORTED THAT THE SURGERY WAS NOT DELAYED DUE TO THE HEADLIGHT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21314934 ↗MalfunctionJan 23, 2025Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible
IT WAS REPORTED THAT THE DUO HEADLIGHT AND CARRYING CASE (90600) "HEATS A LOT, AND NOISE" WAS NOTED "IN THE FAN." THERE WAS NO PATIENT INVOLVEMENT; THUS, NO INJURY, DEATH, OR SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21220644 ↗MalfunctionDec 6, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE LIGHT OF THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) FLICKERS ABOUT AN HOUR AFTER USE, AND THE LIGHT WAS GETTING HOT. THERE WAS NO PATIENT INVOLVEMENT; THUS, NO PATIENT INJURY, DEATH OR SURGICAL DELAY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20861393 ↗MalfunctionNov 1, 2024Overheating of Device; Intermittent Energy Output; Overheating of Device; Intermittent Energy Output
IT WAS REPORTED THAT THE LIGHT OF THE DUO HEADLIGHT 2 BAY SYSTEM-US (90620US) WAS FLICKERING AND GETTING HOT. THERE WAS NO PATIENT INVOLVEMENT; THUS, NO INJURY, DEATH, OR SURGICAL DELAY HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20587424 ↗
Other Integra Lifesciences (Ireland) Limited products
All Integra Lifesciences (Ireland) Limited devices →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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