Integra® 00MLXRecalls & reported problems

Summary

The FDA's MAUDE database contains 189 adverse event reports that list this exact device (DI 10381780168140), received between Jul 28, 2021 and Sep 21, 2026 — classified as 189 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (87 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 189 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Smoking

  A facility reported that the MLX 300W XENON LIGHTSOURCE (00MLX) makes a burning smell when the light was turned on. The device was not in contact with a patient; no patient injury or surgical delay has been reported

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846695 ↗
• MalfunctionSep 21, 2026Smoking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846694 ↗
• MalfunctionSep 21, 2026Smoking

  A facility reported that the MLX 300W XENON LIGHTSOURCE (00MLX) worked as intended when used in the operating room (OR). However, when the device was powered on and used by technicians, they noticed a burning smell. The device was taken out of service, and troubleshooting was initiated in the shop. Ultimately, no faults or exact source of the odor could be identified. The device was not in contact with a patient, and no patient injury or surgical delay was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841658 ↗
• MalfunctionSep 14, 2026Overheating of Device

  A facility reported that the MLX 300W XENON LIGHTSOURCE (00MLX) light box sparked during use. It is unknown if there was a patient involvement; however, no injuries, deaths, or surgical delays were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50753040 ↗
• MalfunctionMay 18, 2026Overheating of Device

  A FACILITY REPORTED THAT THE MLX 300W XENON LIGHTSOURCE (00MLX) UNIT HAD A STRONG SMELL, AND THEY FOUND THAT THE RUBBER HAD MELTED INTO THE LIGHT ASSEMBLY HOLDER. THERE WAS NO PATIENT INJURY, DEATH, OR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25203698 ↗
• MalfunctionApr 27, 2026Smoking

  A FACILITY REPORTED THAT THE MLX 300W XENON LIGHTSOURCE (00MLX) HAD A CONFIRMED BURN SMELL DURING USE. IT WAS UNKNOWN IF THE PRODUCT WAS IN CONTACT WITH THE PATIENT, BUT NO INJURY, DEATH, OR SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001559 ↗
• MalfunctionApr 27, 2026Smoking

  A FACILITY REPORTED THAT THE MLX 300W XENON LIGHTSOURCE (00MLX) EMITTED A BURNING SMELL. THERE WAS NO PATIENT INVOLVEMENT, NO INJURY, DEATH, OR SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000710 ↗
• MalfunctionApr 3, 2026Overheating of Device

  A FACILITY REPORTED THAT PRODUCT MLX 300W XENON LIGHTSOURCE (00MLX) WAS OVERHEATING. IT WAS EVALUATED AND DISCOVERED THAT THE MIRROR FELL OUT OF PLACE, AND THE HOLDER FOR THE MIRROR WAS DEFECTIVE. THERE WAS NO PATIENT INVOLVEMENT; THUS, NO PATIENT INJURY OR SURGICAL DELAYS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24783894 ↗
• MalfunctionMar 20, 2026Overheating of Device

  A FACILITY REPORTED THAT THE MLX 300W XENON LIGHTSOURCE (00MLX) SMOKES WHEN USED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT OR IF THE DEVICE FAILURE LED TO PATIENT INJURY OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650842 ↗
• MalfunctionMar 19, 2026Smoking

  A FACILITY REPORTED THAT THE MLX 300W XENON LIGHTSOURCE (00MLX) HAD A STRONG BURNT ODOR WHEN IT WAS ON. IT WAS ALSO REPORTED THAT THE LCD DISPLAY WAS DEFECTIVE. THERE WAS NO PATIENT INVOLVEMENT, NO INJURY, DEATH, OR SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24644387 ↗
• MalfunctionMar 11, 2026Smoking

  A FACILITY REPORTED THAT THE NEW LIGHT MODULE OF THE MLX 300W XENON LIGHTSOURCE (00MLX) UNIT WAS PRODUCING A BURNING SMELL. THERE WAS NO PATIENT INVOLVEMENT, NO INJURY, DEATH OR SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24569986 ↗
• MalfunctionMar 6, 2026Smoking

  A FACILITY REPORTED THAT THE UNIT MLX 300W XENON LIGHTSOURCE (00MLX) WAS PRODUCING A BURNING SMELL WHEN USED WITH A NEW LIGHT MODULE. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO INJURIES, DEATHS, OR SURGICAL DELAYS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531200 ↗
• MalfunctionMar 3, 2026Overheating of Device

  THIS IS 2 OF 2 REPORTS AND IS RELATED TO MFG NUMBER 3006697299-2025-00139. A FACILITY REPORTED THAT APPROXIMATELY 20 MINUTES INTO AN EAR, NOSE, AND THROAT (ENT) PROCEDURE, THE MLX 300W XENON LIGHTSOURCE (00MLX) SHUT OFF, WITH THE CORD BEING DESCRIBED AS HOT OR MELTING. ANOTHER LIGHT SOURCE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT INJURIES, DEATHS, OR SURGICAL DELAYS. THE INITIAL REPORT DID NOT INDICATE THAT 00MLX WAS OVERHEATING. OVERHEATING OF THE 00MLX WAS DISCOVERED DURING THE FAILURE AND ROOT CAUSE ANALYSIS OF THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24495488 ↗
• MalfunctionMar 2, 2026Smoking

  A FACILITY REPORTED THAT THE MLX 300W XENON LIGHTSOURCE (00MLX) SMELLED SMOKY AND WOULD NOT TURN ON. IT IS UNKNOWN UNDER WHAT CIRCUMSTANCE THIS EVENT OCCURRED; HOWEVER, NO INJURY AND NO DEVICE CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491511 ↗
• MalfunctionMar 2, 2026Overheating of Device

  A FACILITY REPORTED THAT THE MLX 300W XENON LIGHTSOURCE (00MLX) HAD A CONNECTION FAILURE BETWEEN THE HEAD LIGHT AND THE DEVICE, AND IT CAUSED BURNS ON THE MAIN DEVICE FROM OVERHEATING. THERE WAS NO PATIENT INVOLVEMENT, THUS NO INJURIES, DEATH, OR SURGICAL DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24485939 ↗
• MalfunctionMar 2, 2026Smoking

  A FACILITY REPORTED THAT THE MLX 300W XENON LIGHTSOURCE (00MLX) HAD A BURNING SMELL. THEY REPORTED THAT THEY "OPENED THE DEVICE AND FOUND THAT THE HOLDER FOR THE IR GLASS THAT IS LOCATED IN FRONT OF THE LIGHT BULB." IT IS UNKNOWN WHETHER THERE WAS PATIENT INVOLVEMENT, INJURY, DEATH, OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482577 ↗
• MalfunctionFeb 22, 2026Overheating of Device; Smoking

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24410540 ↗
• MalfunctionJan 12, 2026Smoking; Complete Loss of Power

  A FACILITY REPORTED THAT WHEN THE MLX 300W XENON LIGHTSOURCE (00MLX) WAS TURNED ON, IT STARTED SMOKING AND NOW DOES NOT POWER ON. THERE WAS NO PATIENT INVOLVEMENT; THUS, NO INJURIES, DEATH, OR DELAYS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24035805 ↗
• MalfunctionJan 5, 2026Break; Smoking

  A FACILITY REPORTED THAT THE MLX 300W XENON LIGHTSOURCE (00MLX) WAS FOUND TO BE BROKEN AND EMITTING SMOKE FROM THE FRONT OPENING. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO INJURIES, DEATHS, OR SURGICAL DELAYS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23960599 ↗
• MalfunctionDec 4, 2025Break; Smoking; Intermittent Energy Output; Break; Smoking; Intermittent Energy Output

  A FACILITY REPORTED THAT THE MLX 300W XENON LIGHTSOURCE (00MLX) BRACKET INSIDE THE HOLD GLASS SQUARE WAS BROKEN, WAS SMOKING THROUGH THE FRONT HOLE, WAS FLICKERING, AND HAD NO LIGHT. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO INJURIES, DEATHS, OR SURGICAL DELAYS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720824 ↗
• MalfunctionNov 18, 2025Smoking; Smoking

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23578224 ↗
• MalfunctionNov 4, 2025Smoking; Smoking

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23468983 ↗
• MalfunctionOct 15, 2025Smoking; Smoking

  A FACILITY REPORTED THAT THE MLX 300W XENON LIGHTSOURCE (00MLX) UNIT HAD A BURNING SMELL. THERE WAS NO PATIENT INVOLVEMENT; THUS, NO INJURY, DEATH, OR SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23297005 ↗
• MalfunctionSep 11, 2025Smoking; Smoking

  A FACILITY REPORTED THAT THE MLX 300W XENON LIGHTSOURCE (00MLX) UNIT STARTED SMOKING WHEN THE LIGHT WAS TURNED ON. THEN, WHEN THE MLX WAS TURNED OFF, IT WOULD NOT POWER ON AT ALL. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO DEATH, INJURY, OR SURGICAL DELAYS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025956 ↗
• MalfunctionSep 8, 2025Overheating of Device; Smoking; Overheating of Device; Smoking

  A FACILITY REPORTED THAT THE LIGHT SOURCE OF MLX 300W XENON LIGHTSOURCE (00MLX) WAS EMITTING TOO MUCH HEAT, WHICH CAUSED THE CABLE TO BURN ON THE INTEGRA HEADSET. 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 22992670 ↗