Fluoride Varnish Packaging Error: Wrong Flavor Variant in White Mint Package
Young Dental Manufacturing is recalling Benco Dental iris 5% fluoride varnish packages labeled White Mint because they may contain Bubblegum varnish instead. The recall affects 344 boxes distributed to Florida, Nevada, and Pennsylvania.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Class II FDA medical device recall for labeling/packaging error. No illnesses or injuries have been reported. The hazard is product mislabeling—the wrong flavor variant shipped in the labeled package—which constitutes a minor labeling error.
Plain-English summary
Young Dental Manufacturing is recalling Benco Dental iris 5% Fluoride Varnish products because packages labeled White Mint (Item #4323-635, Lot 207540) may contain Bubblegum varnish instead. The affected lot has an expiration date of September 30, 2024, and the UDI/DI is 00366975000590.
The recall impacts 344 boxes distributed to dental facilities in Florida, Nevada, and Pennsylvania.
Healthcare providers who received this product should verify the actual contents of their packages and check patient records if this product was used. The contents of the affected packages do not match their labeling. Providers should contact Young Dental Manufacturing with any questions or to arrange return of the product.
The recalled product
- Product
- BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish
- Manufacturer
- Young Dental Manufacturing I, LLC
- Category
- Medical Device — Dental Products
- Affected units
- 344
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI/DI 00366975000590
- Lot number 207540
- Exp. 20240930
Distribution
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