Young Dental Recalls Oral-B Fluoride Varnish Due to Shelf Life Labeling
Young Dental Manufacturing Co, LLC is recalling Oral-B 5% Sodium Fluoride Varnish because the product shelf life may be shorter than indicated on the label.
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: The recall is classified as FDA Class II and involves a labeling discrepancy regarding shelf life. No illnesses, injuries, or specific high-risk pathogens are reported, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Young Dental Manufacturing Co, LLC is recalling Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each). The recall involves Batch 84702 and Batch 72766, with 6,500 units in each batch. The product is used for dentinal hypersensitivity and for the reduction of post-operative sensitivity.
The recall was initiated because the product shelf life may be shorter than that indicated on the label. The agency classified this as a Class II recall. The product was distributed nationwide in the states of MS, IN, MD, IL, TN, NJ, and ME.
Consumers and dental practitioners should stop using the affected product and contact Young Dental Manufacturing Co, LLC for further instructions.
The recalled product
- Product
- Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product Usage: For dentinal hypersensitivity and for the reduction of post-operative sensitivity.
- Manufacturer
- Young Dental Manufacturing Co, LLC
- Hazard
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 (2)
- Batch 84702
- Batch 72766
Distribution
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