Recall archive / FDA device enforcement
BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish — FDA record Z-1697-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 23, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Young Dental Manufacturing I, LLC
- Quantity
- 344 boxes
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1697-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI/DI 00366975000590, Lot number 207540, Exp. 20240930 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution to Florida, Nevada, and Pennsylvania.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jun 14, 2023
- Recall initiation date
- May 23, 2023
- Center classification date
- Jun 8, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.