UltraLite® AX2100BIFRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10381780168850), received between Jun 21, 2022 and May 1, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (4 reports).

8 other recalls cover devices cleared under the same FDA submission (K864380); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2025Overheating of Device; Intermittent Loss of Power; Overheating of Device; Intermittent Loss of Power

  IT WAS REPORTED THAT THE LIGHT CORD OF THE ULTRALITE PRO HEADLIGHT W/PREMIUM CABLE (AX2100BIF) WAS "WORKING INTERMITTENTLY, NOW THE HEADLAMP WON'T WORK AT ALL." THE FACILITY REPORTED THAT THE CORD GOT "HOT TO TOUCH." IT IS UNKNOWN UNDER WHAT CIRCUMSTANCE THIS EVENT OCCURRED. THE DEVICE WAS NOT IN CONTACT WITH A PATIENT; THUS, NO PATIENT INJURY, DEATH OR SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943770 ↗
• MalfunctionSep 5, 2024Overheating of Device; Overheating of Device

  A FACILITY REPORTED THAT THE OPERATOR SMELLED BURNT FUMES WHILE USING THE ULTRALITE PRO HEADLIGHT W/PREMIUM CABLE (AX2100BIF). NO VISUAL SMOKE WAS DETECTED. THE UNIT WAS TURNED OFF AND PLACED OUT OF SERVICE. NO PATIENT INJURY OR SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20154078 ↗
• MalfunctionNov 10, 2022Crack; Overheating of Device; Crack; Overheating of Device

  THE FOLLOWING INFORMATION WAS REPORTED VIA MEDSUN UF/IMPORTER REPORT# (B)(4): "HEAD LAMP USED BY SURGEON WAS NOTED TO HAVE CRACKED INSULATION/WIRE CAUSING HEAT TO BUILD UP (FIRE HAZARD). NOTICED DURING PLUGGING/UNPLUGGING FOR XRAY INTRA-OP. THE UNIT WAS SWITCHED OUT WITH NEW ONE. TEST PERFORMED (B)(6) 2022; RESULTS: HEADLAMP SENT TO BIOMED DEPARTMENT FOR EVALUATION AND CORRECTION. HAVE 2 NEW HEADLAMPS ON ORDER." NO PATIENT/USER INJURY, DEATH OR SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15775314 ↗
• MalfunctionJun 21, 2022Overheating of Device; Overheating of Device

  A FACILITY REPORTED THAT THERE WAS BROKEN GLASS OR MIRROR AT THE LAMP OF THE ULTRALITE PRO HEADLIGHT W/PREMIUM CABLE (AX2100BIF) AND THE UNIT EMITS MULTIPLE LIGHT FOCUS AREAS. THIS WAS DISCOVERED BY THE FACILITY¿S BIOMED FOLLOWING REPORT OF OVERHEATING. THE BIOMED REPORTEDLY FOUND NO ISSUE WITH THE UNIT BUT DURING TESTING, THE DAMAGE TO THE HEADLAMP WAS DISCOVERED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO INJURY, DEATH OR SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14760365 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K864380. One submission often covers many models, so check the product and lot details in each record.

• Z-0377-2012 · Oct 10, 2011 · Terminated
  Luxtec UltraLite Headlight System sweatband Model: AXI385BIF Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light sour
• Z-0376-2012 · Oct 10, 2011 · Terminated
  Luxtec UltraLite Headlight System with short linkage Model: AX 1375BIFSL Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensit
• Z-0373-2012 · Oct 10, 2011 · Terminated
  Luxtec UltraLite Pro Headlight with 9ft bifurcated cable Model: AX2000BIF Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensit
• Z-0375-2012 · Oct 10, 2011 · Terminated
  Luxtec UltraLite Headlight System Headband Model: AXI375BIF Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light sourc
• Z-0381-2012 · Oct 10, 2011 · Terminated
  UltraLite Headlight module-grey Model: 001328 Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgica
• Z-0380-2012 · Oct 10, 2011 · Terminated
  Mark II Headlight module-black with short linkage Model: 001380LXSL Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity li
• Z-0378-2012 · Oct 10, 2011 · Terminated
  Luxtec UltraLite Headlight System sweatband with short linkage Model: AXI385BIFSL Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high
• Z-0374-2012 · Oct 10, 2011 · Terminated
  Luxtec UltraLite Headlight System with 9ft premium bifurcated cable Model: AX2100BIF Product Usage: The fiber optic headlight system Is designed to deliver illumination from a h