SafeLight 0233050200Recalls & reported problems
Stryker Corporation · Fiber Optic Light Cable, Grey · Class 2
All models of SafeLight (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327051643), received between Nov 22, 2021 and Sep 9, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Failure to Shut Off” (2 reports).
1 FDA recall record name this device's 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, 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
Recalls naming this device
- Mar 2, 2023Class IIOpen, 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Shut Off2
- Optical Problem1
- Output Problem1
- Thermal Decomposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702444 ↗MalfunctionDec 8, 2021Thermal Decomposition of Device; Failure to Shut Off; Failure to Shut Off
IT WAS REPORTED THAT THERE WAS A POTENTIAL OF A THERMAL EVENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12965848 ↗MalfunctionNov 22, 2021Failure to Shut Off; Output Problem; Failure to Shut Off
IT WAS REPORTED THAT THERE WAS THE POTENTIAL OF A THERMAL EVENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12858126 ↗
Other Light source, fiberoptic, routine devices
- Integra® 00MLXIntegra Lifesciences (Ireland) Limited · Light source, fiberoptic, routine189 reports
- L9000 0220210000Stryker Corporation · Light source, fiberoptic, routine99 reports
- SafeLight 0233050100Stryker Corporation · Light source, fiberoptic, routine1 recall22 reports
- SafeLight 0233050087Stryker Corporation · Light source, fiberoptic, routine59 reports
- IRIS 0220180518Stryker Corporation · Light source, fiberoptic, routine43 reports
- n.a. 495NDKarl Storz GmbH & Co. KG · Light source, fiberoptic, routine23 reports
- PRECISION 0220220000Stryker Corporation · Light source, fiberoptic, routine22 reports
- n.a. 495NCSCKarl Storz GmbH & Co. KG · Light source, fiberoptic, routine19 reports
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 · each recall links to the FDA recall notice
- 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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