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Integra® 90500Recalls & reported problems

Integra Lifesciences Production Corporation · Integra® LED Headlight Only · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780168485), received between Jul 22, 2022 and Jul 22, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Overheating of Device” (1 report).

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.

Most reported problems

Device problems

  • Overheating of Device1
  • Unexpected Shutdown1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 22, 2022Overheating of Device; Unexpected Shutdown; Overheating of Device; Unexpected Shutdown

    A FACILITY REPORTED THAT THE LED HEADLIGHT ONLY (90500) WAS OVERHEATING AND SWITCHING ITSELF OFF. THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY IN SURGERY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15084284 ↗

Other Light, headband, surgical devices

All Light, headband, surgical devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.