Class II — CARESTREAM DENTAL, LLC
| Recalling firm | Carestream Dental LLC |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The mirror may become detached and fall from the unit |
| Product | 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. |
| Quantity | 11400 devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of WA, MD, WV, NE, SC, NJ, FL, OH, CA, OR, LA, MO, NY, MI, MA, ID, TN, GA, MN, NC, PA, AZ, OK, IN and the country of Canada. |
| Initiated | 2021-02-15 |
| Classified | 2021-03-17 |
| Terminated | 2023-01-14 |
| Recall number | Z-1268-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — CARESTREAM DENTAL, LLC (Z-1268-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87443/
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