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FDASeptember 1, 2023device

Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked

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

The hazard

It has been found that potential unintended laser activation can occur without foot pedal depression.

What to do

FDA enforcement status: Ongoing

Brands named

convergent dentalconvergent

UPCs

0085063400701800850634007001

Recall history

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

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