Discus Dental Recalls Relief ACP Oral Care Gel Due to Filling Error
Discus Dental LLC is recalling Relief ACP Oral Care Gel because some units were filled with hydrogen peroxide instead of phosphate gel, potentially causing increased sensitivity.
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 the source text indicates the hazard is limited to a neutral effect or increased sensitivity, with no reports of serious injury or hospitalization.
Plain-English summary
Discus Dental LLC is voluntarily recalling specific lots of Relief ACP Oral Care Gel, a product intended to relieve discomfort from dentin sensitivity. The recall affects units sold in single, single syringe, 4 packs, 6 packs, and teeth whitening kits. The affected products were distributed nationwide in the U.S. and internationally in countries including New Zealand, Australia, Canada, Germany, and others.
The recall is due to a manufacturing error where products sold after April 1, 2014, were inadvertently filled with hydrogen peroxide teeth whitening gel (6% concentration) on one side of the dual barrel syringe instead of the intended phosphate gel. This error may result in a neutral effect or increased sensitivity for patients using the product.
Consumers should stop using the affected products and check their lot numbers against the list provided by the FDA. The recall covers 20,251 units distributed in the U.S. and 14,653 units distributed internationally.
The recalled product
- Product
- Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single syringe, 4 packs, 6 packs and in teeth whitening kits
- Manufacturer
- Discus Dental LLC
- Category
- Medical Device — Dental Care
Distribution
Distributed nationwide across the United States.
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