L11 0220230300Recalls & reported problems
Stryker Corporation · LED Light Source with Advanced Imaging Modality · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker L11 LED light source has 229 adverse event reports, including 221 malfunctions, 8 injuries and no deaths. The reports mostly describe the light turning on or off by itself, touch panels not responding, and the light staying on and burning through a drape and injuring a patient. No recalls name this device. Reports fell from 39 in the previous 12 months to 14 in the most recent 12 months.
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
- 233
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 233 adverse event reports that list this exact device (DI 07613327455915), received between Jul 18, 2019 and Sep 24, 2026 — classified as 8 injuries, 225 malfunctions.
The most frequently reported specific device problem is “Output Problem” (126 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Output Problem126
- Temperature Problem55
- Optical Problem38
- No Display/Image19
- Adverse Event Without Identified Device or Use Problem10
- Overheating of Device10
- Poor Quality Image9
- Thermal Decomposition of Device9
Patient problems
- No Clinical Signs, Symptoms or Conditions193
- Insufficient Information62
- No Known Impact Or Consequence To Patient31
- Burn(s)12
- No Consequences Or Impact To Patient4
- Superficial (First Degree) Burn4
- Burn, Thermal3
- No Patient Involvement2
Recent adverse event reports
The 25 most recent of 233 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886492 ↗MalfunctionSep 23, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862956 ↗MalfunctionSep 15, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781665 ↗MalfunctionSep 9, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702141 ↗MalfunctionSep 2, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50576725 ↗MalfunctionSep 1, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50554188 ↗MalfunctionAug 31, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50534268 ↗MalfunctionAug 12, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50230106 ↗MalfunctionAug 12, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50230105 ↗MalfunctionAug 7, 2026Overheating of Device; Temperature Problem
Patient problems: Burn(s)
MAUDE report 50168668 ↗MalfunctionJun 30, 2026Optical Problem; Output Problem
IT WAS REPORTED THAT TURNING OFF DURING CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25668906 ↗MalfunctionMay 29, 2026Optical Problem
IT WAS REPORTED THAT THERE WAS LIGHT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25335872 ↗MalfunctionApr 13, 2026Optical Problem
IT WAS REPORTED THAT THE LIGHT KEPT TURNING ON AND OFF DURING THE PROCEDURE. SOMETIMES IT WOULD DISAPPEAR FOR JUST A SECOND, AND OTHER TIMES IT WOULD STAY OFF FOR ABOUT 30 SECONDS. MULTIPLE INSTANCES OF THE LIGHT TURNING OFF WITHIN A SINGLE CASE¿NOT SEPARATE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24867464 ↗MalfunctionMar 26, 2026Optical Problem; Output Problem
IT WAS REPORTED THAT LIGHT DISAPPEARED ABOUT TWO HOURS INTO THE PROCEDURE. PROCEDURE COMPLETED USING REPLACEMENT. THEY HAVE INSPECTED THE FSE AND WERE UNABLE TO REPRODUCE THE REPORTED DEFECT. THEY ARE CURRENTLY CONDUCTING ONGOING OBSERVATION AT THE FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700344 ↗MalfunctionDec 23, 2025Connection Problem; Optical Problem; Connection Problem; Optical Problem
IT WAS REPORTED THAT L11 SHUT OFF DURING A CASE. WHEN THEY TRIED TO TURN ON THE L11, THE RING AROUND THE LIGHT CABLE WAS ON AND BLINKING BUT THE POWER BUTTON WAS GREYED OUT. THEY WERE NOT ABLE TO TURN IT ON AND WHEN THEY WERE TROUBLESHOOTING IT, THEY CHECKED TO SEE IF THE LIGHT CABLE PORT WAS DAMAGED OR LOSE AND IF THE AUTO LIGHT FEATURE WAS OFF. THEY TESTED A NEW LIGHT CABLE AND THE PORT LOOKED FINE. THEY ALSO CONFIRMED THAT THE AUTO LIGHT FEATURE WAS OFF, BUT THE POWER BUTTON WAS STILL GREYED OUT. CASE WAS COMPLETED AND THERE WAS PATIENT CARE DELAY BUT WAS NOT REPORTED IF THERE WAS HARM. THE CASE WAS ALSO WRAPPING UP WHEN WHILE THEY WERE TROUBLESHOOTING. THEREFORE, THERE WAS A LOSS OF LIGHT.
Patient problems: Insufficient Information
MAUDE report 23882514 ↗MalfunctionDec 23, 2025Connection Problem; Optical Problem; Connection Problem; Optical Problem
IT WAS REPORTED THAT L11 SHUT OFF DURING A CASE. WHEN THEY TRIED TO TURN ON THE L11, THE RING AROUND THE LIGHT CABLE WAS ON AND BLINKING BUT THE POWER BUTTON WAS GREYED OUT. THEY WERE NOT ABLE TO TURN IT ON AND WHEN THEY WERE TROUBLESHOOTING IT, THEY CHECKED TO SEE IF THE LIGHT CABLE PORT WAS DAMAGED OR LOSE AND IF THE AUTOLIGHT FEATURE WAS OFF. THEY TESTED A NEW LIGHT CABLE AND THE PORT LOOKED FINE. THEY ALSO CONFIRMED THAT THE AUTO LIGHT FEATURE WAS OFF, BUT THE POWER BUTTON WAS STILL GREYED OUT. CASE WAS COMPLETED AND THERE WAS PATIENT CARE DELAY BUT WAS NOT REPORTED IF THERE WAS HARM. THE CASE WAS ALSO WRAPPING UP WHEN WHILE THEY WERE TROUBLESHOOTING. THEREFORE, THERE WAS A LOSS OF LIGHT.
Patient problems: Insufficient Information
MAUDE report 23882511 ↗MalfunctionDec 5, 2025Connection Problem; Optical Problem; Connection Problem; Optical Problem
IT WAS REPORTED THAT LIGHT SOURCE WOULD SHUT OFF OVER TIME. THERE WAS LOSS OF LIGHT FOR 30 SECONDS UNTIL MANUAL RESTARTING OF UNIT. HAPPENED AGAIN THEN SWAPPED UNITS. PROCEDURE COMPLETED USING ANOTHER DEVICE. THEY HAD TO SWAP OUT THE UNIT CAUSING 2 MINS DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23728587 ↗MalfunctionNov 25, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT KNOB DOESN'T CLICK IN PLACE ALL THE WAY AND LIGHT CORD WAS BURNED DURING PROCEDURE. PROCEDURE WAS COMPLETED AND DEVICE WAS REPLACED AFTER EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23650605 ↗MalfunctionOct 27, 2025Optical Problem; Output Problem; Optical Problem; Output Problem
IT WAS REPORTED THAT DURING A CASE LIGHT WAS TURNING OFF AND THEY WERE UNABLE TO TURN IT BACK ON. THE LED RING AROUND THE LIGHT PORT WAS ON AND THE AUDIBLE BEEP WOULD SOUND WHEN TRYING TO TURN THE LIGHT BACK ON, BUT THE LIGHT WOULD NOT TURN ON. NO OTHER INFORMATION WAS AVAILABLE REGARDING TROUBLESHOOTING STEPS OR PATIENT/STAFF IMPACT. THEY SWITCHED OUT THE BOX DURING THE CASE AND THE REPLACEMENT LIGHT BOX WORKED WITH THE LIGHT CORD THEY HAD BEEN USING.
Patient problems: Insufficient Information
MAUDE report 23396092 ↗MalfunctionOct 24, 2025Optical Problem; Output Problem; Optical Problem; Output Problem
IT WAS REPORTED THAT LIGHT SOURCE IS GETTING OFF AFTER CONNECTING THE LIGHT CABLE. PROCEDURE COMPLETED USING REPLACEMENT DEVICE. THERE WAS FULL LOSS OF LIGHT FOR AROUND 30 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23383079 ↗MalfunctionOct 23, 2025Optical Problem; Output Problem; Optical Problem; Output Problem
IT WAS REPORTED THAT LOSS OF LIGHT WAS EXPERIENCED DURING USE AND DURATION OF LOSS OF LIGHT IS UNKNOWN. PROCEDURE COMPLETED USING SAME DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23374519 ↗MalfunctionOct 21, 2025Optical Problem; Optical Problem
IT WAS REPORTED THAT L11 LIGHT SOURCE SN (B)(6) SHUT OFF DURING CASE, CAUSED A 10 MINUTE DELAY. THERE WAS FULL LOSS OF LIGHT FOR APPROXIMATELY 30 SECONDS BEFORE GETTING ANOTHER SOURCE. CASE COMPLETED WITH THE HELP OF REPLACEMENT DEVICE FROM ANOTHER ROOM. NO INFORMATION ABOUT MEDICAL INTERVENTION IS PROVIDED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23350924 ↗MalfunctionOct 15, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THERE WAS BURNING PLASTIC SMELL AND E2 ERROR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23299652 ↗MalfunctionAug 29, 2025Optical Problem; Output Problem; Optical Problem; Output Problem
IT WAS REPORTED THAT THE DEVICE WENT ON STANDBY DURING CASE AND THE SURGICAL SCREEN WENT BLACK. THE PATIENT WAS AWAKE. STAFF HAD TO TURN THE LIGHT SOURCE BACK ON TO CONTINUE. CASE SUCCESSFULLY COMPLETED. SLIGHT DELAY IN CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22925899 ↗MalfunctionAug 21, 2025Optical Problem; Output Problem; Optical Problem; Output Problem
IT WAS REPORTED THAT THE LIGHT SOURCE WAS FLICKERING WHEN USING THE 1588 AND 1688 CAMERAS, SO THE RECORDING OF EACH CAMERA WHEN IN USE WAS CHECKED, AND THE LIGHT SOURCE OPERATION WAS INSPECTED BY CONNECTING THE LIGHT CABLE TO THE L10 AND L11 CAMERAS. THE FLICKERING WAS CONFIRMED TO BE FLICKERING LIGHT OUTPUT. ADDITIONAL INFORMATION REGARDING THE EVENT, SUCH AS A POTENTIAL FOR A FULL LOSS OF LIGHT AND THE DURATION COULD NOT BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22868655 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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