Data Foundry

Medical device recalls 2014

BencoDental tartar & stain remover ultrasonic cleaning solution… — Class II medical device recall Z-1133-2014

Terminated recall by Heraeus Kulzer, LLC., reported 2014-03-12, distributed nationwide. As the result of a complaint to Heraeus Kulzer's customer service department, Heraues Kulzer is recalling Benc

Recall numberZ-1133-2014
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmHeraeus Kulzer, LLC., South Bend, IN, United States
Recall initiated2014-02-10
Classified2014-03-04
Reported by FDA2014-03-12
Terminated2014-06-18
DistributedNationwide (US)
Quantity812 units
Reason classeslabeling
Lot numbers13121434
Model numbers1010-451

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.

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1133-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.