Light, Surgical, Accessories
FDA adverse event reports and recall history for light, surgical, accessories (product code FTA), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 368
- Deaths
- 0
- Injuries
- 12
- Malfunctions
- 354
Reports per year
Source: FDA adverse event reports by year received, 2009–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2023-04-28Open, ClassifiedUnder Investigation by firm
Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including disposable surgical light handle covers are designed to fit over surgical light handles for sterile surgeon control. REF: LB53
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
- 2023-04-28Open, ClassifiedUnder Investigation by firm
Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, single use) used to drape the lighthandle of STERIS surgical lighting systems for the purpose of maintaining a sterile surgical environment. REF: LB44
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
- 2007-07-24TerminatedOther
Sunnex Celestial Star MR-16 (lamp holder) Medical Examination Lighting used in Model Numbers: CS2050C (ceiling mount), CS2050W (wall mount). CS2050D (dual mount) , CS2050M (mobile).
Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder.
- 2007-07-24TerminatedOther
Tri-Star Surgical Exam Light MR-16 ( Lamp Holder) used in the following: Model Numbers: TS2015W (wall mount) , TS2015M (mobile) , TS2015W (wall mount) , TS2035M (mobile)
Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder.
- TerminatedUnder Investigation by firm
Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device inside a peel pouch and sealed. Sealed pouches are packaged 10 each inside a poly liner. 5 rows of 10 pouches are placed in a labeled corrugated mailer box. Product Usage: Intended to be used as a disposable barrier for a surgical lighting system and which allows a surgical team member to manually adjust the lighting system. Single use device.
Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch.
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