Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Gluma Desensitizer Power Gel Product Usage: Usage: This is a Recalled by Heraeus Kulzer, LLC. Due to The firm discovered that the Gluma Desensitizer Power...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Heraeus Kulzer, LLC. directly.
Affected Products
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 teeth to receive fixed prosthesis or restorations.
Quantity: 5,112 syringes or 1,278 kits (1 Kit=4 syringes)
Why Was This Recalled?
The firm discovered that the Gluma Desensitizer Power Gel can be inadvertently extruded from the application syringe all at once when it is supposed to extrude on the desired area a small amount at a time. If extruded all at once, product could reach the dental patients mucosa, face or eyes or the dental professional could be exposed. This would cause irritation, burning or blistering.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Heraeus Kulzer, LLC.
Heraeus Kulzer, LLC. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report