BencoDental Tartar and Stain Remover Recalled for Incorrect Labeling
Heraeus Kulzer is recalling BencoDental tartar and stain remover due to incorrect labeling on the immediate container.
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 minor labeling error on the immediate container, which fits the rubric criteria for moderate severity.
Plain-English summary
Heraeus Kulzer, LLC. is recalling BencoDental tartar and stain remover ultrasonic cleaning solution, part #1010-451, lot #13121434. The recall was initiated following a complaint to the company's customer service department regarding incorrect labeling on the immediate container.
The product is formulated for the removal of calculus, tartar, tobacco, and food stains from dentures, bridges, and orthodontic appliances, as well as for the removal of permanent cement. While the outer carton correctly identifies the product as "Benco Tartar and Stain," the immediate gallon container incorrectly states "Benco Temporary C".
A total of 812 units (gallons) were distributed nationwide in the United States, specifically in the states of AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MI, MN, MO, MS, NC, ND, NE, NM, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, and WV. Consumers and dental professionals should check their inventory for this specific lot number and part number and stop using the product if it matches the recalled description.
The recalled product
- Product
- BencoDental tartar & stain remover ultrasonic cleaning solution Product Usage: Formulated especially for removal of calculus, tartar, tobacco and food stains from dentures, bridges, orthodontic appliances, etc. Use also for removal of permanent cement.
- Manufacturer
- Heraeus Kulzer, 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 (1)
- Part #1010-451 Lot #13121434
Distribution
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