Reported Mar 24, 2021 · Terminated

Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to record the…

Carestream Dental, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: CARESTREAM DENTAL, LLC · 3625 Cumberland Blvd Se Ste 700 · Atlanta, GA · 30339-6406

Is this the product you have?

  • Carestream Dental CS 3600 Single Use Normal Tips
  • Catalog Number 5941216 - Product Usageused to record the topographic characteristics of teeth or dental impressions in three dimensions
Lot codes and dates
  • All lot numbers
Amount recalled
11400 devices

Where it was sold

Why it was recalled

The mirror may become detached and fall from the unit

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 14, 2023 · Data as of Sep 19, 5:43 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.