L12 0220240300Recalls & reported problems
Stryker Corporation · L12 LED LIGHT SOURCE WITH AIM · Class 2
Quick summary
This is the Stryker L12 LED light source used to illuminate surgical fields. There are 24 adverse event reports naming it: most describe the unit overheating, giving off a burning smell or smoke, catching fire at the cord, or losing light during procedures. One injury was reported, including burns, and no deaths. 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
- 24
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 07613327572124), received between Jun 5, 2024 and Aug 18, 2026 — classified as 1 injury, 23 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (10 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.
Reports received per month
Most reported problems
Device problems
- Overheating of Device10
- Optical Problem8
- Output Problem5
- Temperature Problem4
- Electrical Power Problem2
- Electrical Shorting1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- Insufficient Information5
- Burn(s)2
- Unspecified Tissue Injury1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50311072 ↗MalfunctionAug 17, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50288683 ↗MalfunctionAug 11, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50216344 ↗MalfunctionAug 5, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50150118 ↗MalfunctionJul 28, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50062274 ↗MalfunctionMay 29, 2026Overheating of Device
IT WAS REPORTED THAT DEVICE FLICKERED, THEN SHUT OFF AND WOULD NOT TURN BACK ON. NOTICED BURNT SMELL. THEREFORE, THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25331198 ↗MalfunctionJan 7, 2026Overheating of Device
IT WAS REPORTED THAT ON ONE OF THE COLD LIGHTS (SN: (B)(6), THE NURSING STAFF SMELLED SOMETHING BURNING COMING FROM THE COLD LIGHT AND SAW SMOKE. THEREFORE, THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23995818 ↗MalfunctionDec 17, 2025Overheating of Device; Electrical Shorting; Optical Problem; Overheating of Device; Electrical Shorting; Optical Problem
IT WAS REPORTED THAT FIRE CAUSED FROM THE DISTAL END OF CORD UNIT. UNIT TURN ITSELF OFF TWICE DURING CASE. PROCEDURE COMPLETED USING SAME DEVICE. THERE WAS FULL LOSS OF LIGHT FOR 2 MINUTES PROBABLY AND REBOOTING THE LIGHT SOURCE FIXED THE PROBLEM EACH TIME. DEVICE REBOOTING WAS OBSERVED AFTER DRAPE BURN. HENCE THERE IS A THERMAL EVENT AND LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23830498 ↗MalfunctionDec 4, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT FIRST DEGREE BURN WAS IDENTIFIED AT THE END OF THE CASE ON PATIENT¿S ABDOMEN. NURSE REMOVED THE SAFELIGHT ADAPTER FROM SCOPE RATHER THAN CORD, CAUSING THE LIGHT TO REMAIN ON AND BURN THE PATIENT.
Patient problems: Burn(s)
MAUDE report 23721795 ↗MalfunctionNov 20, 2025Electrical Power Problem; Optical Problem; Electrical Power Problem; Optical Problem
IT WAS REPORTED THAT THE TOUCHSCREEN ON THEIR CONNECTED OR HUB HAS STOPPED WORKING. IT WAS FURTHER REPORTED THAT THEIR L12 LIGHT SOURCE HAS SHUT OFF TO STANDBY MODE. STAFF ATTEMPTED TO GET THE LIGHT SOURCE WORKING AGAIN FOR A COUPLE OF MINUTES WITH NO LUCK. THEREFORE, THERE WAS A FULL LOSS OF LIGHT. THE PROCEDURE WAS COMPLETED USING DIFFERENT TOWER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23612444 ↗InjuryOct 6, 2025Optical Problem; Output Problem; Optical Problem; Output Problem
IT WAS REPORTED THAT DUE TO ICG NOT WORKING, THEY HAD A PROBLEM IDENTIFYING THE URETER, AND BECAUSE OF THIS, THE SURGEON THINKS THE URETER AND BLADDER WAS INJURED SO WE HAD TO CALL AN ON-CALL UROLOGIST TO CHECK ON THE BLADDER AND URETER. THEATRE TIME WAS PROLONGED. PATIENT WAS EXPOSED TO LONGER ANESTHETIC AGENT. PATIENT NEEDED TO BE ADMITTED FOR FURTHER CARE AND TREATMENT." PER ADDITIONAL INFORMATION RECEIVED FROM THE ACCOUNT, THE FAILURE RESULTED IN AN INJURY MIGHT HAVE BEEN CAUSED BY THERMAL FROM DIATHERMY. A LEAK TEST WAS DONE WITH BLADDER FILED WITH METHYLENE BLUE BUT NO OBVIOUS LEAKS, RETROGRADES WERE PERFORMED WITH X-RAY ATTENDANCE AND NO LEAK ON URETER. EVEN THOUGH THERE ARE NO OBVIOUS LEAK, BOTH SURGEONS STILL DECIDE TO TREAT IT AS BLADDER INJURY. URETERIC STENT WAS INSERTED. CATHETER WAS INSERTED AND PLANNED TO BE LEFT FOR 2 WEEKS, AND STENT BE REMOVED AFTER 6 WEEKS. CATHETER WAS PUT IN TO OBSERVE ANY POST-SURGICAL BLEEDING. THE ICG USED WAS VERDYE GREEN 5MG/ML (INDOCYANIN GREEN) AND IS NOT A STRYKER PRODUCT.
Patient problems: Insufficient Information; Unspecified Tissue Injury
MAUDE report 23228429 ↗MalfunctionSep 30, 2025Optical Problem; Optical Problem
THIS EVENT WAS INITIALLY REPORTED AS A MALFUNCTION FOR LOSS OF LIGHT. UPON ADDITIONAL INFORMATION PROVIDED, THIS EVENT IS NO LONGER REPORTABLE. PER ADDITIONAL INFORMATION RECEIVED, THE SURGEON LOSS VISIBILITY DUE TO LOSS OF LIGHT FOR SEVERAL SECONDS. THIS EVENT DESCRIPTION MOST LIKELY INDICATES ¿NO LIGHT OUTPUT¿. THE REVIEW OF HISTORICAL COMPLAINT DATA, RISK DOCUMENTATION, AND THE REPORTED INFORMATION REGARDING THIS EVENT DO NOT SUGGEST A RECURRENCE OF THIS EVENT WOULD BE LIKELY TO RESULT IN A SERIOUS INJURY. NO ADVERSE CONSEQUENCES WERE DETERMINED TO BE REPORTABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23187063 ↗MalfunctionAug 29, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE PATIENT WAS BURNED WITH THE LIGHT CORD. IT WAS A 1ST DEGREE BURN, THE SIZE WAS SMALLER THAN A DIME. THE SURGEON DISCONNECTED LIGHT CORD FROM THE SCOPE EARLY IN THE PROCEDURE AND THE LIGHT BOX TURNED OFF. AT THE END OF THE PROCEDURE THE SURGEON DISCONNECTED THE LIGHT CORD FROM THE SCOPE AND PUT CAMERA HEAD AND LIGHT CORD ON THE DRAPE. THE TECH NOTICED THE DISTAL END OF LIGHT CORD BURNED THROUGH THE DRAPE. AFTER INVESTIGATING FURTHER, THE LIGHT CORD BURNED THROUGH PATIENT GOWN AS WELL.
Patient problems: Burn(s)
MAUDE report 22925182 ↗MalfunctionAug 20, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE SAFELIGHT CABLE DID NOT DE-ACTIVATE WHEN TAKING OFF ADAPTER. THEREFORE, THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22854078 ↗MalfunctionAug 12, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT A HOLE WAS BURNED INTO THE DRAPE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22786203 ↗MalfunctionJun 25, 2025Electrical Power Problem; Optical Problem; Output Problem; Electrical Power Problem; Optical Problem; Output Problem
IT WAS REPORTED THAT THE INSTALLED LIGHT SOURCE HAS A FAULTY ELECTRICAL CONNECTION THAT TURNS ITSELF ON AND OFF. THEREFORE, THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22332756 ↗MalfunctionMay 29, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE STAFF PLUGGED IN A LIGHT CORD TO L12. ONCE PLUGGED IN, THE CORD WAS SITTING ON DRAPE NOT PLUGGED INTO ANY ADAPTERS ETC. IT WAS ON AND BECOMING HOT. BURNED/MELTED TINY HOLE IN DRAPE HOLE PUNCH SIZE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22107710 ↗MalfunctionFeb 19, 2025Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: Insufficient Information
MAUDE report 21416174 ↗MalfunctionJan 14, 2025Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS A LOSS OF LIGHT.
Patient problems: Insufficient Information
MAUDE report 21154204 ↗MalfunctionJan 14, 2025Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: Insufficient Information
MAUDE report 21154201 ↗MalfunctionAug 9, 2024Temperature Problem; Temperature Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19956474 ↗MalfunctionAug 7, 2024Temperature Problem; Temperature Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19935501 ↗MalfunctionAug 7, 2024Temperature Problem; Temperature Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19935499 ↗MalfunctionJun 5, 2024Temperature Problem; Temperature Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19472958 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.