The Recall Desk

Manufacturer

Heraeus Kulzer, LLC.

2 recalls in our database name Heraeus Kulzer, LLC. as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2014-05-28

Of the 2 recalls from Heraeus Kulzer, LLC. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • HighFDA (Devices)·Z-1651-2014·2014-05-28

    Heraeus Kulzer Recalls Gluma Desensitizer Power Gel Due to Extrusion Risk

    Heraeus Kulzer is recalling Gluma Desensitizer Power Gel because it may extrude all at once, causing irritation, burning, or blistering to patients or dental professionals.

    Product
    Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination of pain in exposed cervical areas that do not require restoration. It is also used for alleviation or reduction of dentinal sensitivity after preparation of teet
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1133-2014·2014-03-12

    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.

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide