CLASS II Device recall · Reported 12 Mar 2014 · FDA Enforcement Report

BencoDental tartar & stain remover ultrasonic cleaning solution recalled

Heraeus Kulzer is recalling BencoDental tartar & stain remover ultrasonic cleaning solution, distributed nationwide in the US. The recall was initiated on 10 Feb 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart #1010-451 Lot #13121434

Quantity recalled812 units (gallons)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1133-2014
FDA event ID: 67475
Recalling firm: Heraeus Kulzer, South Bend, IN
Classification: Class II
Status: Terminated
Recall initiated: 10 Feb 2014
FDA classified: 4 Mar 2014
Reported: 12 Mar 2014
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Labeling Errors
Device type: Dental Devices

Timeline

10 Feb 2014	Recall initiated by company
4 Mar 2014	Classified by FDA	+22 days
12 Mar 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

As the result of a complaint to Heraeus Kulzer's customer service department, Heraues Kulzer is recalling Benco Tartar and Stain Solution part #1010-451, lot #13121434 because it has incorrect labeling on the immediate container. While the outer carton correctly states "Benco Tartar and Stain", the immediate gallon container in which the solution is contained incorrectly states "Benco Temporary C

Product as listed by the FDA

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.

Where it was distributed

USA Nationwide Distribution in the states 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, WV

Nationwide Alabama Arkansas Arizona California Colorado Florida Georgia Illinois Indiana Kansas Kentucky Louisiana Michigan Minnesota Missouri Mississippi North Carolina North Dakota Nebraska New Mexico

Questions about this recall

Why was it recalled?

Which lots are affected?

Part #1010-451 Lot #13121434

Where was it sold?

USA Nationwide Distribution in the states 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, WV

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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