FDA Device recall Z-0476-2015
Dharma Cavity Varnish 15mL
- FDA Device
- Class II
- terminated
- Published 2014-12-03
On 2014-12-03 the FDA classified a Class II recall of Dharma Cavity Varnish 15mL by Dharma Research, citing during an FDA inspection it was found that the products are marketed without a cleared 510k.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0476-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-29 |
| Published | 2014-12-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Dharma Research |
| Distribution | CA, FL, IL, PA, PR |
Product
Dharma Cavity Varnish 15mL
Reason
During an FDA inspection it was found that the products are marketed without a cleared 510k.
Identifiers
| code_info | All Lots - Item # 14-00016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0476-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.