FDA Device recall Z-1697-2023
BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635
- FDA Device
- Class II
- ongoing
- Published 2023-06-14
On 2023-06-14 the FDA classified a Class II recall of BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635 by Young Dental Manufacturing I, citing the Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1697-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-23 |
| Published | 2023-06-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Young Dental Manufacturing I |
| Distribution | FL, NV, PA |
Product
BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish
Reason
The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum.
Identifiers
| code_info | UDI/DI 00366975000590, Lot number 207540, Exp. 20240930 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1697-2023%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.