Latex Dental Dams labeled as Non-Latex Dental Dams — Class II medical device recall Z-2151-2014
Terminated recall by Coltene Whaledent Inc, reported 2014-08-13, distributed in TN. Colt¿ne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. During an interna
| Recall number | Z-2151-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Coltene Whaledent Inc, Cuyahoga Falls, OH, United States |
| Recall initiated | 2013-12-11 |
| Classified | 2014-08-06 |
| Reported by FDA | 2014-08-13 |
| Terminated | 2016-08-26 |
| Distributed | TN |
| Lot numbers | 103G2, 2016/10 |
| Model numbers | 1884-10840 |
Product
Latex Dental Dams labeled as Non-Latex Dental Dams
Reason for recall
Colt¿ne/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.
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-2151-2014. 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.