FDA Device recall Z-0741-2018
Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only
- FDA Device
- Class II
- terminated
- Published 2018-03-07
On 2018-03-07 the FDA classified a Class II recall of Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only by Cosmedent, citing product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0741-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-28 |
| Published | 2018-03-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cosmedent |
| Distribution | IL, LA, MI, PA, WI |
Product
Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.
Reason
Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.
Identifiers
| code_info | SKU #663-103, Lot No. 164222A, Exp. Date 10/31/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0741-2018%22
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