L9000 0220210000Recalls & reported problems
Stryker Corporation · LED Light Source · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker L9000 LED light source is a fiberoptic light for medical procedures. Its 99 adverse event reports include no deaths, 5 injuries and 94 malfunctions. The reports mostly describe the light going out or losing power, and overheating or thermal events, and some describe burns to patients. 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
- 99
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 07613327051339), received between Dec 11, 2018 and Nov 27, 2024 — classified as 5 injuries, 94 malfunctions.
The most frequently reported specific device problem is “Output Problem” (42 reports).
1 other recall cover devices cleared under the same FDA submission (K082813); 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. 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 Problem42
- No Display/Image33
- Electrical /Electronic Property Problem17
- Intermittent Loss of Power11
- Loss of Power9
- Adverse Event Without Identified Device or Use Problem5
- Electrical Power Problem5
- Temperature Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions50
- No Known Impact Or Consequence To Patient45
- Insufficient Information34
- Burn(s)2
- Burn, Thermal2
- Superficial (First Degree) Burn2
- No Code Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 99 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 27, 2024Electrical Power Problem; Output Problem; Electrical Power Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20800107 ↗MalfunctionAug 14, 2024Output Problem; Temperature Problem; Output Problem; Temperature Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19986246 ↗MalfunctionJun 5, 2024Electrical Shorting; Output Problem; Electrical Shorting; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19472425 ↗MalfunctionDec 21, 2023Connection Problem; Temperature Problem; Connection Problem; Temperature Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18375676 ↗MalfunctionMay 9, 2023Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16898782 ↗MalfunctionApr 3, 2023Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16663722 ↗MalfunctionMar 30, 2023Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16649528 ↗MalfunctionAug 4, 2022Loss of Power; Output Problem; Loss of Power
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15163115 ↗InjuryJun 21, 2022Temperature Problem; Adverse Event Without Identified Device or Use Problem; Temperature Problem
IT WAS REPORTED THAT THERE WAS PATIENT BURN.
Patient problems: Burn(s); Superficial (First Degree) Burn
MAUDE report 14762297 ↗MalfunctionJun 13, 2022Smoking; Smoking
IT WAS REPORTED THAT THE DEVICE WAS SMOKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14679456 ↗MalfunctionMay 20, 2022Thermal Decomposition of Device; Temperature Problem; Temperature Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT DURING PROCEDURE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14452851 ↗MalfunctionFeb 22, 2022Output Problem
IT WAS REPORTED THAT THERE WAS A POTENTIAL OF ADVERSE CONSEQUENCES DUE TO LOSS OF LIGHT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13579051 ↗MalfunctionJan 7, 2022Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13192375 ↗MalfunctionJan 6, 2022Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13176871 ↗MalfunctionNov 17, 2021Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12833128 ↗MalfunctionNov 10, 2021Output Problem; No Device Output; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12789173 ↗MalfunctionNov 2, 2021No Display/Image; Output Problem; No Display/Image; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12740891 ↗MalfunctionNov 1, 2021Output Problem; Environmental Compatibility Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12733648 ↗MalfunctionSep 30, 2021Electrical Power Problem; Electrical /Electronic Property Problem; Electrical Power Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12555432 ↗MalfunctionSep 30, 2021Output Problem; Electrical /Electronic Property Problem; Mechanical Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12555423 ↗MalfunctionSep 3, 2021Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12425145 ↗MalfunctionAug 31, 2021No Display/Image; Electrical /Electronic Property Problem; No Display/Image
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12393889 ↗MalfunctionAug 26, 2021Mechanical Problem; Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12374924 ↗MalfunctionAug 12, 2021No Device Output; Output Problem; No Device Output; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12315309 ↗MalfunctionAug 5, 2021Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12285072 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K082813. One submission often covers many models, so check the product and lot details in each record.
- Z-1474-2023 · Mar 2, 2023 · Open, ClassifiedSafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200
Other Light source, fiberoptic, routine devices
- Integra® 00MLXIntegra Lifesciences (Ireland) Limited · Light source, fiberoptic, routine189 reports
- SafeLight 0233050100Stryker Corporation · Light source, fiberoptic, routine1 recall22 reports
- SafeLight 0233050087Stryker Corporation · Light source, fiberoptic, routine59 reports
- SafeLight 0233050200Stryker Corporation · Light source, fiberoptic, routine1 recall3 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
- 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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