Carestream Dental CS 3600 Single Use Normal Tips — Class II medical device recall Z-1268-2021
Terminated recall by CARESTREAM DENTAL, LLC, reported 2021-03-24, distributed nationwide. The mirror may become detached and fall from the unit
| Recall number | Z-1268-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CARESTREAM DENTAL, LLC, Atlanta, GA, United States |
| Recall initiated | 2021-02-15 |
| Classified | 2021-03-17 |
| Reported by FDA | 2021-03-24 |
| Terminated | 2023-01-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 11,400 devices |
| Reason classes | device malfunction |
| Model numbers | 5941216 |
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.
Reason for recall
The mirror may become detached and fall from the unit
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1268-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.