Integra® Duo 90620USRecalls & reported problems
Integra Lifesciences (Ireland) Limited · Integra® DUO Integra® DUO Headlight 2 Bay System - US · Class 2
All models of Integra Duo (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Integra Duo surgical headlight is a two-bay light system worn on a headband during operations. Most of the 33 reports describe the light overheating, usually because the cooling fan stopped working, which made the light flicker, strobe, or shut off mid-procedure, along with some electrical shorting and power loss. There are no deaths and 1 injury. 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
- 33
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10381780490746), received between Dec 2, 2021 and May 27, 2026 — classified as 1 injury, 32 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (24 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
- Overheating of Device24
- Electrical Shorting5
- Intermittent Energy Output4
- Insufficient Heating2
- Intermittent Loss of Power2
- Adverse Event Without Identified Device or Use Problem1
- Defective Component1
- Melted1
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- Headache1
- Pain1
Recent adverse event reports
The 25 most recent of 33 reports, 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 ↗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
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 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 ↗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 ↗MalfunctionSep 23, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE DUO HEADLIGHT 2 BAY SYSTEM: US (90620US) WAS OVERHEATING AND FLICKERING. THERE WAS NO PATIENT INVOLVEMENT, THUS NO INJURY, DEATH, OR SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20284286 ↗MalfunctionJul 7, 2024Insufficient Heating; Overheating of Device; Insufficient Heating; Overheating of Device
IT WAS REPORTED THAT THE DUO HEADLIGHT 2 BAY SYSTEM (90620US) FLICKERS DUE TO TOP COOLING FAN NOT WORKING. THE UNIT WOULD OPERATE NORMALLY FOR THE FIRST TEN MINUTES THEN PROCEEDED TO FLICKER WHEN THE MODULE GOT HOT. NO PATIENT INJURY, DEATH OR SURGICAL DELAY HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19686889 ↗MalfunctionJul 2, 2024Insufficient Heating; Overheating of Device; Insufficient Heating; Overheating of Device
A FACILITY REPORTED THAT THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) WORKS INTERMITTENTLY AND GETS HOT WHEN IN USE. THERE WAS NO PATIENT INVOLVEMENT AND NO SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19662467 ↗MalfunctionJun 7, 2024Overheating of Device; Overheating of Device
A FACILITY REPORTED THAT THERE WAS A LIGHT MALFUNCTION WITH THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US). THE LIGHT WOULD "FLICKER" DUE TO THE TOP COOLING FAN NOT WORKING. THE DUO HEADLIGHT WOULD OPERATE NORMALLY FOR THE FIRST TEN MINUTES, THEN PROCEED TO ¿FLICKER¿ WHEN THE MODULE BECAME HOT. IT WAS REPORTED THAT THERE WAS NO DELAY IN SURGERY AS A REPLACEMENT DEVICE WAS AVAILABLE FOR USE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19487243 ↗MalfunctionJun 1, 2024Overheating of Device; Optical Problem; Overheating of Device; Optical Problem
A FACILITY REPORTED THAT AFTER 20 MINUTES OF USE, THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) STARTED TO OVERHEAT AND THE BEAM BEGAN TO FLICKER. THERE WAS NO PATIENT INVOLVEMENT; THUS, NO PATIENT INJURY, DEATH OR SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19443235 ↗MalfunctionMay 13, 2024Overheating of Device; Overheating of Device
A FACILITY REPORTED THAT THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) WAS OVERHEATING, CAUSING THE FAN TO FLICKER. IT IS UNKNOWN UNDER WHAT CIRCUMSTANCE THIS EVENT OCCURRED; HOWEVER, NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19303491 ↗MalfunctionFeb 15, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE LED HOUSING OF THE DUO HEADLIGHT 2 BAY SYSTEM - US ((B)(6)) HAS PULLED APART AND HAD BECOME AN INFECTION RISK. IN ADDITION, THE RUBBER GROMMET FOR ELECTRICAL CORD IS DRY ROTTED, THE BATTERY HOLDER WAS MISSING A COUPLE OF SLIM NUTS SO THE POWER CONNECTOR ON THE BATTERY PACK CUTS POWER AND OVERHEATS. IT IS UNKNOWN UNDER WHAT CIRCUMSTANCE THIS EVENT WAS DISCOVERED. NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18715832 ↗MalfunctionSep 8, 2023Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE COOLING FAN OF THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) OPERATED INTERMITTENTLY, CAUSING THE LIGHT TO OVERHEAT AND FLICKER. IT IS UNKNOWN UNDER WHAT CIRCUMSTANCE THIS EVENT OCCURRED; HOWEVER, NO PATIENT INJURY, DEATH OR SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17716543 ↗MalfunctionJul 3, 2023Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE COOLING FAN OF THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) OPERATED INTERMITTENTLY, CAUSING THE LIGHT TO OVERHEAT & FLICKER. IT IS UNKNOWN UNDER WHAT CIRCUMSTANCE THIS EVENT OCCURRED; HOWEVER, NO PATIENT INJURY, DEATH OR SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17247220 ↗MalfunctionMay 18, 2023Overheating of Device; Overheating of Device
A FACILITY REPORTED THAT THE COOLING FAN ON THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) WAS NOT WORKING; THE LIGHT GOES ON AND OFF AFTER OVERHEATING. IT IS UNKNOWN UNDER WHAT CIRCUMSTANCE THIS EVEN OCCURRED; HOWEVER, NO PATIENT INJURY OR SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16957124 ↗MalfunctionApr 3, 2023Electrical Shorting; Electrical Shorting
A FACILITY REPORTED THAT THE CORD LEADING TO THE BATTERY PACK OF THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) HAS A SHORT IN IT. NO PATIENT/USER INJURY, DEATH OR SURGICAL DELAY OCCURRED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16664715 ↗MalfunctionMar 3, 2023Overheating of Device; Overheating of Device
A FACILITY REPORTED THAT THE LIGHT OF DUO HEADLIGHT 2 BAY SYSTEM (90620US) WAS FLICKERING ON AND OFF. ADDITIONALLY, THE LED LAMP SEEMED TO BE GETTING EXCESSIVELY HOT. NO PATIENT INJURY, DEATH OR SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16477784 ↗MalfunctionJan 30, 2023Overheating of Device; Overheating of Device
A FACILITY REPORTED THAT THE LIGHT OF THE DUO HEADLIGHT AND CARRYING CASE (B)(4) WAS "FLICKERING ON AND OFF". IN ADDITION, THE LED LAMP SEEMED TO BE "GETTING EXCESSIVELY HOT". IT WAS REPORTED THAT THE EVENT OCCURRED DURING A CASE. THE DEVICE WAS NOT IN CONTACT WITH A PATIENT. NO INJURY, DEATH OR SURGICAL DELAY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16263958 ↗InjuryDec 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MalfunctionNov 17, 2022Overheating of Device; Overheating of Device
A FACILITY REPORTED THAT THE LIGHT OF THE DUO HEADLIGHT 2 BAY SYSTEM (90620US) WAS GETTING TOO HOT. IT IS UNKNOWN UNDER WHICH CIRCUMSTANCE THIS EVENT OCCURRED; HOWEVER. NO INJURY, DEATH OR SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15817385 ↗
Other Light, headband, surgical devices
- Integra® Duo 90600Integra Lifesciences (Ireland) Limited · Light, headband, surgical10 reports
- Integra® Duo 90622Integra Lifesciences (Ireland) Limited · Light, headband, surgical2 reports
- Welch Allyn, Inc. 901067Welch Allyn, Inc. · Light, headband, surgical1 report
- Integra® 90500Integra Lifesciences Production Corporation · Light, headband, surgical1 report
- Integra® 90520USIntegra Lifesciences Production Corporation · Light, headband, surgical1 report
- Welch Allyn, Inc. 901069Welch Allyn, Inc. · Light, headband, surgical1 report
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.
How reports and recalls are matched · Editorial policy · Report an error on this page