HexaLux HexaLux Ceiling Mount (REF EXLCEIL)Recalls & reported problems
Steris Corporation · The HexaLux Ceiling-Mount Light is a powerful, next-generation LED exam light designed to be used in a multitude of rooms including the exam room, birthing suite, or intensive care unit. · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00724995244286), received between Jul 9, 2025 and Apr 22, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component4
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2026Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THEIR HEXALUX CEILING-MOUNTED SURGICAL LIGHT DETACHED AND FELL FROM THE CEILING. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24955423 ↗MalfunctionDec 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THEIR HEXALUX EXAMINATION LIGHT PARTIALLY DETACHED WHILE BEING REPOSITIONED, CONTACTING BOTH A PATIENT AND A USER FACILITY EMPLOYEE. IT WAS REPORTED THAT BOTH THE PATIENT AND USER FACILITY EMPLOYEE WERE INJURED; HOWEVER, THE EXTENT OF THE ALLEGED INJURIES, OR ANY RESULTING MEDICAL TREATMENT HAS NOT BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 23832383 ↗MalfunctionAug 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THEIR HEXALUX SURGICAL LIGHT DETACHED FROM THE CEILING. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22897274 ↗MalfunctionJul 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THEIR HEXALUX EXAMINATION LIGHT DETACHED FROM THE CEILING. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22461877 ↗
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- Hillrom™ 4058110Baxter Medical Systems GmbH + Co. KG · Device, medical examination, ac powered4 reports
- HexaLux HexaLux Ceiling MountSteris · Device, medical examination, ac powered4 reports
- Chromophare F300 CE2863075Berchtold Holding GmbH · DEVICE, MEDICAL EXAMINATION, AC POWERED2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.