The Recall Desk
ModerateFDA (Devices)·Z-1133-2014·Announced 2014-03-12

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.

What this means for you

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.

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

Distributed nationwide across the United States.

The notice also names 32 states specifically:

Same manufacturer · Heraeus Kulzer, LLC.

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