Integra® Duo 90600Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10381780491064), received between Aug 16, 2022 and Feb 4, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (7 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionAug 4, 2024Overheating of Device; Power Problem; Overheating of Device; Power Problem

  IT WAS REPORTED THAT THE DUO HEADLIGHT AND CARRYING CASE (90600) HAS A COOLING FAN ISSUE. THE FAN DOES NOT COME ON, OVERHEATS THE LIGHT AND TURNS OFF. THERE WAS NO PATIENT INVOLVEMENT, THUS NO INJURY, DEATH, OR SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19902957 ↗
• MalfunctionAug 4, 2024Overheating of Device; Power Problem; Overheating of Device; Power Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19902956 ↗
• MalfunctionJun 7, 2023Overheating of Device; Overheating of Device

  A FACILITY REPORTED THAT THERE WAS A PROBLEM WITH THE DUO HEADLIGHT AND CARRYING CASE (B)(4). THE STAFF REPORTED THAT THE UNIT BEGAN TO EMIT A BURNT SMELL. WHEN THE TECHNICIANS TESTED THE UNIT, THEY COULD NOT GET THE LIGHT TO START AT ALL, ALTHOUGH THE BATTERY SHOWED A FULL CHARGE. THE TECHNICIANS ALSO TRIED CONNECTING THE HEADLIGHT VIA POWER CABLE WITHOUT SUCCESS. THEY SUSPECTED THAT THE PROBLEM WAS IN THE BATTERY AND INDICATED THAT IS WHERE THE SMELL WAS COMING FROM. THE PRODUCT WAS NOT IN CONTACT WITH A PATIENT. NO PATIENT INJURY, DEATH OR SURGICAL DELAY OCCURRED. FINAL USER: (B)(6) HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17079719 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A

  Patient problems: Headache

  MAUDE report 16916668 ↗
• MalfunctionApr 14, 2023Connection Problem; Connection Problem

  A FACILITY REPORTED THAT DURING SURGERY, THERE WAS BAD CONTACT BETWEEN THE CABLE AND THE BATTERY OF THE DUO HEADLIGHT AND CARRYING CASE (90600). THE SURGERY WAS STOPPED UNTIL THE DOCTOR'S PARTNER COULD LEND HIS HEADLIGHT. IT WAS REPORTED THAT THE SURGERY WAS DELAYED FOR 30 MINUTES. THERE WAS CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16745266 ↗
• MalfunctionSep 24, 2022Overheating of Device; Overheating of Device

  A FACILITY REPORTED THAT THE DUO HEADLIGHT AND CARRYING CASE (90600) WAS FLICKERING INTRA-OPERATIVELY. NO PATIENT INJURY, DEATH OR SURGICAL DELAY WAS REPORTED. UPON FURTHER ASSESSMENT BY AN INTEGRA DEPOT TECHNICIAN, IT WAS NOTED THAT THE DUO HEADLIGHT/LED WAS OVERHEATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15476155 ↗
• InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DUO HEADLIGHT (90600) WAS TOO UNCOMFORTABLE FOR THE SURGEON. SHE TRIED FOR THREE DAYS AND THE HEADLIGHT GAVE HER SEVERE HEADACHES. THERE WAS NO REPORTED PATIENT INJURY AND NO DELAY IN SURGERY REPORTED.

  Patient problems: Headache

  MAUDE report 15230946 ↗