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Integra® 90520USRecalls & reported problems

Integra Lifesciences Production Corporation · Integra® LED Headlight with Batteris & AC/DC Power Supply - US · 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 10381780168607), received between Jul 8, 2021 and Jul 8, 2021 — 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

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 8, 2021Overheating of Device; Overheating of Device

    A FACILITY MADE A REPAIR REQUEST FOR THE LED HEADLIGHT (90520US) WITH THE REASON FOR REQUEST STATING "HEADLIGHT OVERHEATS." ADDITIONAL INFORMATION WAS SOUGHT FROM THE FACILITY AND WE RECEIVED THE FOLLOWING INFORMATION: "I ASSUME THE OVERHEATING HAPPENED DURING PROCEDURE; HOWEVER, I ONLY RECEIVED UNIT TO SEND AS A REPAIR, DON'T KNOW ALL THE DETAILS." NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12140419 ↗

Other Light, headband, surgical devices

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