Class II — Coltene Whaledent Inc
| Recalling firm | Coltene/Whaledent AG |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Coltne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. During an internal investigation, the firm found that Latex dental dams had been packaged in Non-Latex packaging. |
| Product | Latex Dental Dams labeled as Non-Latex Dental Dams |
| Quantity | 32 boxes, 15 individual dams per box |
| Distribution | Distributed in Memphis, TN. |
| Initiated | 2013-12-11 |
| Classified | 2014-08-06 |
| Terminated | 2016-08-26 |
| Recall number | Z-2151-2014 |
| 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 — Coltene Whaledent Inc (Z-2151-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67640/
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