FDAApril 4, 2018device

Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry. The labeling did not provide specific details for intended use. Distributed by Henry Schein Inc., Melville, NY.

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

The hazard

Tip of the curing light was too hot causing a heat sensation in the patients.

What to do

FDA enforcement status: Ongoing

Brands named

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Recall history

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

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