FDAJanuary 11, 2024device

Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.

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

The hazard

The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece.

What to do

FDA enforcement status: Ongoing

Brands named

brasseler usa i lpbrasselerbrasseler usa

UPCs

00887919188483

Recall history

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

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