NA Lighthandle Cover (REF LB51)Recalls & reported problems
Steris Corporation · The STERIS Harmony Surgical Light Handle Cover is a sterilizable consumable (disposable, single use) used to drape the light handle, camera housing, and flat screen monitor handles for the purpose of maintaining a sterile surgical environment. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 50724995156386), received between May 24, 2023 and Apr 3, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).
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
- Detachment of Device or Device Component3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE DISTRIBUTOR REPORTED THAT TWO OF THE LB51 LIGHTHANDLE COVERS DETACHED AND FELL INTO THE STERILE FIELD DURING A PATIENT PROCEDURE. USER FACILITY PERSONNEL RE-ESTABLISHED THE STERILE FIELD RESULTING IN A PROCEDURE DELAY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21766836 ↗MalfunctionMay 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THEY ARE RECEIVING "MISSHAPED" LB51 LIGHT HANDLE COVERS THAT DO NOT FIT PROPERLY ON THE SURGICAL LIGHTS CAUSING THEM TO FALL INTO THE STERILE FIELD. USER FACILITY PERSONNEL REMOVED AND REPLACED THE FALLEN COVERS AND REESTABLISHED THE STERILE FIELD RESULTING IN A PROCEDURE DELAY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16999272 ↗MalfunctionMay 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE DISTRIBUTOR REPORTED THAT ONE OF THE LB51 LIGHT HANDLE COVERS DETACHED AND FELL INTO THE STERILE FIELD DURING A PATIENT PROCEDURE. USER FACILITY PERSONNEL REMOVED AND REPLACED THE FALLEN COVER AND REESTABLISHED THE STERILE FIELD RESULTING IN A PROCEDURE DELAY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16993663 ↗
Other INSTRUMENT, MANUAL, SURGICAL, GENERAL USE devices
- Arthrex® AR-13995NArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE430 reports
- Arthrex® AR-12990NArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE197 reports
- Arthrex® AR-13991NArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE128 reports
- Arthrex® AR-8981-08SArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall3 reports
- Arthrex® AR-8981-06SArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall1 report
- HarmonyAIR LAS0042Steris Corporation · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall0 reports
- Centurion EB16Centurion Medical Products Corporation · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall0 reports
- Centurion Medical Products Corp SUT15830AMedline Industries, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall0 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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