Cosmedent's Etching Gel — Class II medical device recall Z-0741-2018
Terminated recall by Cosmedent, Inc., reported 2018-03-07, distributed in IL, LA, MI, PA, WI. Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the ma
| Recall number | Z-0741-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cosmedent, Inc., Chicago, IL, United States |
| Recall initiated | 2017-09-28 |
| Classified | 2018-02-27 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2020-10-05 |
| Distributed | IL, LA, MI, PA, WI |
| Countries outside the US | AU, ES, HU |
| Quantity | 84 units |
| Lot numbers | 164222A |
| Expiration dates | 2019-10-31 |
Product
Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.
Reason for recall
Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.
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-0741-2018. 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.