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FDAFebruary 15, 2021device

Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to record the topographic characteristics of teeth or dental impressions in three dimensions.

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

The hazard

The mirror may become detached and fall from the unit

What to do

FDA enforcement status: Terminated

Brands named

carestream dentalcarestream

Recall history

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

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