NA Sterile Lighthandle CoverRecalls & reported problems
Steris Corporation · The STERIS Sterile LightHandle 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 Surgical Lights. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This STERIS sterile light handle cover for surgical lights has 93 reports, all describing malfunctions, with no deaths and no injuries. Common reports describe the cover detaching and falling into the sterile field, sometimes causing a short procedure delay. The 1 open recall, from March 2023, concerns covers that may separate during use and affect the sterile field.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 93
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 00724995150136), received between Jul 15, 2021 and May 1, 2026 — classified as 93 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (88 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Mar 17, 2023Class IIOpen, Classified
Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient
Z-1475-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component88
- Contamination1
- Contamination /Decontamination Problem1
- Device Handling Problem1
- Material Puncture/Hole1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions91
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 93 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2026Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR LB53 LIGHT HANDLE COVER DETACHED AND FELL INTO THE STERILE FIELD. THE STERILE FIELD WAS RE-ESTABLISHED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING A SHORT DELAY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25057314 ↗MalfunctionMar 13, 2026Device Handling Problem
THE USER FACILITY REPORTED VIA MEDWATCH # (B)(4) THAT A HAIR WAS FOUND IN THE LIGHTHANDLE COVER. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24590982 ↗MalfunctionJun 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR LB53 LIGHT HANDLE COVER DETACHED AND FELL INTO THE STERILE FIELD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19560070 ↗MalfunctionMay 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE DISTRIBUTOR REPORTED THAT DURING A PATIENT PROCEDURE THEIR LIGHT HANDLE COVER DETACHED AND FELL INTO THE STERILE FIELD CAUSING A PROCEDURE DELAY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19330348 ↗MalfunctionApr 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THEIR LB53 LIGHT HANDLE COVER FELL OFF INTO THE STERILE FIELD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING A SHORT DELAY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19055168 ↗MalfunctionJan 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT DURING A PATIENT PROCEDURE THEIR LIGHT HANDLE COVER DETACHED AND FELL. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18457767 ↗MalfunctionOct 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR LIGHT HANDLE COVER DETACHED AND FELL. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17962425 ↗MalfunctionOct 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT DURING PATIENT PROCEDURES THEIR LIGHT HANDLE COVERS DETACHED AND FELL. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17912534 ↗MalfunctionOct 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT DURING PATIENT PROCEDURES THEIR LIGHT HANDLE COVERS DETACHED AND FELL. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17912431 ↗MalfunctionAug 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE DISTRIBUTOR REPORTED THAT DURING PATIENT PROCEDURES, LIGHT HANDLE COVERS DETACHED AND FELL INTO THE STERILE FIELD. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17445748 ↗MalfunctionJul 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT DURING A PATIENT PROCEDURE THEIR LIGHT HANDLE COVER DETACHED AND FELL. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17362629 ↗MalfunctionJun 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR LIGHT HANDLE COVER DETACHED AND FELL INTO THE STERILE FIELD. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17139151 ↗MalfunctionMay 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED VIA MEDWATCH REPORT (B)(4) THAT DURING A PATIENT PROCEDURE THEIR LIGHT HANDLE COVER DETACHED AND FELL INTO THE STERILE FIELD. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16954298 ↗MalfunctionMay 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED VIA MEDWATCH REPORT (2601800000-2023-8003) THAT DURING A PATIENT PROCEDURE THEIR LIGHT HANDLE COVER DETACHED AND FELL. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16954208 ↗MalfunctionApr 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED VIA MEDWATCH REPORT MW5115695 THAT DURING PATIENT PROCEDURES THE LIGHT HANDLE COVERS DETACH AND FALL INTO THE STERILE FIELD. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16773909 ↗MalfunctionApr 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED VIA MEDWATCH REPORT MW5115693 THAT DURING PATIENT PROCEDURES THE LIGHT HANDLE COVERS DETACH AND FALL INTO THE STERILE FIELD. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16773904 ↗MalfunctionApr 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED VIA MEDWATCH REPORT MW5115694 THAT DURING PATIENT PROCEDURES THE LIGHT HANDLE COVERS DETACH AND FALL INTO THE STERILE FIELD. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16773903 ↗MalfunctionApr 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED VIA MEDWATCH REPORT MW5115692 THAT DURING PATIENT PROCEDURES THE LIGHT HANDLE COVERS DETACH AND FALL INTO THE STERILE FIELD. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16773901 ↗MalfunctionApr 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR LIGHT HANDLE COVER DETACHED AND FELL INTO THE STERILE FIELD. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16731453 ↗MalfunctionApr 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT DURING PATIENT PROCEDURES, LIGHT HANDLE COVERS DETACHED AND FELL INTO THE STERILE FIELD. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16724558 ↗MalfunctionApr 6, 2023Contamination; Contamination
THE USER FACILITY REPORTED VIA MEDWATCH (B)(4)T HAT WHEN A LB53 LIGHT HANDLE COVER WAS OPENED, IT WAS NOTICED THAT SEVERAL BLACK FLECKS WERE ON THE LIGHT HANDLE COVER. THE LIGHT HANDLE COVER WAS NOT UTILIZED AND WAS DISCARDED. THE USER FACILITY UTILIZED ANOTHER LB53 LIGHT HANDLE COVER AND NO ISSUES WERE NOTED. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16696860 ↗MalfunctionApr 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED VIA MEDWATCH REPORT MW5115279 THAT DURING A PATIENT PROCEDURE THEIR LIGHT HANDLE COVER DETACHED AND FELL INTO THE STERILE FIELD. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16683083 ↗MalfunctionApr 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED VIA MEDWATCH REPORT MW5115280 THAT DURING A PATIENT PROCEDURE THEIR LIGHT HANDLE COVER DETACHED AND FELL INTO THE STERILE FIELD. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16683066 ↗MalfunctionApr 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT DURING PATIENT PROCEDURES, LIGHT HANDLE COVERS DETACHED AND FELL INTO THE STERILE FIELD. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16682940 ↗MalfunctionApr 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT DURING A PATIENT PROCEDURE THEIR LIGHT HANDLE COVER DETACHED AND FELL. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16682872 ↗
Other Light, surgical, accessories devices
- Harmony iQ Harmony iQ 3600Black Diamond Video, Inc. · Light, surgical, accessories20 reports
- Maquet Sterigrip ARD567203900Maquet Sas · Light, Surgical, Accessories12 reports
- HexaVue HexaVue-SLC 1.0Black Diamond Video, Inc. · Light, surgical, accessories9 reports
- HexaVue HexaVue IPBlack Diamond Video, Inc. · Light, surgical, accessories7 reports
- NA LB83Steris Corporation · Light, surgical, accessories6 reports
- HexaVue HexaVue FocusBlack Diamond Video, Inc. · Light, surgical, accessories5 reports
- Harmony iQ Harmony iQ 2800Black Diamond Video, Inc. · Light, surgical, accessories3 reports
- Aspen® Flexible Light Handle Cover LT-F01BAspen Surgical Products, Inc. · Light, surgical, accessories3 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page