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FDAMay 31, 2024device

Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWL

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

The hazard

Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

00821925044258

Recall history

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

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