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FDAMarch 17, 2023device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

steris

UPCs

00724995150136

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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