Agency classClass IIOur severity:High FDA (Devices)·Z-1651-2014·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where injury (irritation, burning, blistering) is a direct consequence of the defect, but no specific reported injuries or illnesses are cited in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Heraeus Kulzer, LLC. is recalling 5,112 syringes or 1,278 kits of Gluma Desensitizer Power Gel. The product is a Class II medical device used to reduce pain in exposed cervical areas and alleviate dentinal sensitivity. The recall affects specific lots distributed nationwide in states including GA, TX, IL, CA, WA, WI, HI, MO, FL, NJ, TN, PA, NY, NC, OH, IN, CT, KY, AZ, NV, and IA.

The firm discovered that the gel can be inadvertently extruded from the application syringe all at once instead of in small, controlled amounts. If this occurs, the product could reach the dental patient's mucosa, face, or eyes, or expose the dental professional. This unintended exposure can cause irritation, burning, or blistering.

Dental professionals should stop using the affected lots immediately. Consumers who have had this product used on them should contact their dental provider if they experience irritation, burning, or blistering. The specific lot numbers involved are Syringe Lot 010103 and Kit lots 42 through 48 and 51, with an expiry date of September 2015.

The recalled product

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…
Manufacturer: Heraeus Kulzer, LLC.
Category: Medical Device — Dental
Hazard: chemical-irritation
burn-injury
blistering

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 (8)

Model Number(s): 66043451 Expiry: 2015-09 Syringe Lot number 010103
which are contained within Kit lot numbers 42.43.44.45.46.47.48.49
50
and 51. Note
lots 49 and 50 were captured in house
0 was distributed. Lot 51 was made by the manufacturer
however
never received by us or distributed.

Distribution

Distributed nationwide across the United States.

The notice also names 21 states specifically:

Same manufacturer · Heraeus Kulzer, LLC.

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