SafeLightRecalls & reported problems across all models
Stryker Corporation · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one SafeLight model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 141
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 5 models of SafeLight by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 141 adverse event reports in the FDA's MAUDE database, received between Mar 4, 2019 and Sep 24, 2026 — classified as 1 injury, 140 malfunctions.
The most frequently reported specific device problem is “Output Problem” (81 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
SafeLight recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 2, 2023Open, Classified
Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output issues, which could cause a clinical delay or procedure being converted to open.
Z-1474-2023 · Root cause: Employee error · names 2 of these models · Recall details · FDA record ↗
Most reported SafeLight problems
Device problems
- Output Problem81
- Optical Problem35
- Temperature Problem29
- Connection Problem22
- Overheating of Device10
- Electrical /Electronic Property Problem6
- Failure to Shut Off4
- Energy Output Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions131
- Insufficient Information20
- Burn(s)6
- Superficial (First Degree) Burn3
- No Known Impact Or Consequence To Patient2
SafeLight models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SafeLight 0233050100Light source, fiberoptic, routine1 recall22 reports
- SafeLight 0233050087Light source, fiberoptic, routine59 reports
- SafeLight 0233050400Confocal optical imaging56 reports
- SafeLight 0233050200Light source, fiberoptic, routine1 recall3 reports
- SafeLight 0233050490Confocal optical imaging1 report
Recent SafeLight adverse event reports
The 15 most recent reports across all models, 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 50889815 ↗MalfunctionSep 24, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889811 ↗MalfunctionSep 24, 2026Optical Problem
It was reported that during a pediatric laparoscopic procedure, the light output from the light source unit suddenly turned off. Although the front panel remained illuminated, pressing the ON button did not restore the light output. The ring indicator and light intensity display on the panel remained lit, and the light intensity could still be adjusted. When the power to the unit was turned OFF and then ON again, the light output was restored. However, after being used for a period of time, the same issue recurred. This phenomenon reportedly occurred approximately 3 to 5 times during the procedure. The exact duration of each occurrence is unknown. The light output did not resume automatically. In each instance, the issue was resolved by turning the device off and back on. The procedure was completed with the same device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889799 ↗MalfunctionSep 24, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889798 ↗MalfunctionSep 24, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889497 ↗MalfunctionSep 24, 2026Optical Problem
It was reported that during a pediatric laparoscopic procedure, the light output from the light source unit suddenly turned off. Although the front panel remained illuminated, pressing the ON button did not restore the light output. The ring indicator and light intensity display on the panel remained lit, and the light intensity could still be adjusted. When the power to the unit was turned OFF and then ON again, the light output was restored. However, after being used for a period of time, the same issue recurred. This phenomenon reportedly occurred approximately 3 to 5 times during the procedure. The exact duration of each occurrence is unknown. The light output did not resume automatically. In each instance, the issue was resolved by turning the device off and back on. The procedure was completed with the same device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50888857 ↗MalfunctionSep 10, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50725009 ↗MalfunctionSep 9, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702444 ↗MalfunctionAug 28, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50500585 ↗MalfunctionAug 17, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50288688 ↗MalfunctionAug 6, 2026Overheating of Device
Patient problems: Burn(s)
MAUDE report 50165965 ↗MalfunctionMay 21, 2026Overheating of Device; Electrical Shorting
IT WAS REPORTED THAT LIGHT CABLE DID NOT TURN OFF WHEN ADAPTER/SCOPE WAS REMOVED CAUSING A BURN ON THE PATIENT. FIRST DEGREE BURN TO PATIENT.
Patient problems: Burn(s); Superficial (First Degree) Burn
MAUDE report 25248513 ↗MalfunctionJan 8, 2026Optical Problem; Output Problem
IT WAS REPORTED THAT LIGHT DISAPPEARED ABOUT TWO HOURS INTO THE PROCEDURE. PROCEDURE COMPLETED USING REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24004363 ↗MalfunctionNov 21, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT BURN OCCURRED ON LIGHT CORD, DURING PROCEDURE. POWER WAS NOT ON AND DEVICE HAD BEEN OFF FOR SOME TIME. AND THERE WAS SMOKE IN THE ROOM. PROCEDURE COMPLETED USING ROBOTIC PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23619840 ↗MalfunctionOct 30, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THERE WAS AN OUT OF BOX FAILURE FOR QUANTITY 1 SAFELIGHT OPTIC CORD. THEY WENT LIVE WITH THE NEW EQUIPMENT A WEEK OR TWO AGO AND THE ATTACHED LIGHT CORD DOESN¿T TURN OFF WHEN DISCONNECTED FROM THE SAFELIGHT ADAPTER. THEY HAVE TRIED OTHER LIGHT CORDS / LIGHT SOURCES / ADAPTERS TO NARROW THE CHALLENGE TO THIS LIGHT CORD. THEREFORE, THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23425762 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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