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NA Sterile Camera Handle CoverRecalls & reported problems

Steris Corporation · The STERIS Sterile Camera Handle Covers are designed for HarmonyAIR surgical lights, and provide sterile Control that allow for increasing and decreasing illumination through seven intensity Levels. They are compatible with all Harmony and HarmonyAIR in-light cameras. · 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 00724995150143), received between Feb 17, 2022 and Feb 17, 2022 — classified as 1 malfunction.

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

  • No Apparent Adverse Event1

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.

  • MalfunctionFeb 17, 2022No Apparent Adverse Event; No Apparent Adverse Event

    THE USER FACILITY REPORTED VIA USER FACILITY MEDWATCH REPORT NUMBER MW5105865 THAT THE PACKAGING TRAY OF THEIR LB54 CAMERA LIGHT HANDLE COVER WAS EMPTY. NO REPORT OF INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13549701 ↗

Other Light, surgical, accessories devices

All Light, surgical, accessories devices →

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