HarmonyAIR LAS0036Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00724995217358), received between Apr 18, 2024 and Aug 4, 2026 — classified as 1 injury, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2026Break

  The user facility reported that during a patient procedure the light handle cover to their HarmonyAIR A-Series Surgical Lighting System detached from the light handle; the Cover did not enter the sterile field. The procedure was completed successfully. No report of injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50128628 ↗
• MalfunctionMar 6, 2026Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THEIR HARMONYAIR NG SILICONE STERILIZABLE COVER DETACHED FROM THE LIGHT HANDLE; THE COVER DID NOT ENTER THE STERILE FIELD. NO REPORT OF PROCEDURE DELAY OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24532738 ↗
• MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THEIR HARMONYAIR NG SILICONE STERILIZABLE COVER DETACHED FROM THE LIGHT HANDLE; THE COVER DID NOT ENTER THE STERILE FIELD. NO REPORT OF PROCEDURE DELAY OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23489896 ↗
• MalfunctionMay 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED TWO INCIDENTS OF THEIR HARMONYAIR NG SILICONE STERILIZABLE COVER FALLING OFF INTO THE STERILE FIELD. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19229841 ↗
• MalfunctionApr 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THE SILICONE STERILIZABLE COVER TO THEIR HARMONYAIR A-SERIES LIGHTING SYSTEM DETACHED DURING PATIENT PROCEDURES AND FELL INTO THE STERILE FIELD. A PROCEDURE DELAY WAS REPORTED. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19131575 ↗