FDAClass IIJune 14, 2023

BencoDental iris 5% NaF varnish recall

BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish

Why was BencoDental iris 5% NaF varnish recalled?

The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI 00366975000590, Lot number 207540, Exp. 20240930

Product
BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish
Recalling firm
Young Dental Manufacturing I, LLC
Quantity
344 boxes
Distribution
US distribution to Florida, Nevada, and Pennsylvania.
Recall date
June 14, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls