Z-1651-2014Class II

Gluma Desensitizer Power Gel

Name: Z-1651-2014 Gluma Desensitizer Power Gel
Creator: Heraeus Kulzer, LLC.
Published: 2014-04-23
License: https://open.fda.gov/license/

Kulzer GmbH / initiated 2014-04-23 / Terminated / root cause: manufacturing process

FDA source

Heraeus Kulzer, LLC. began a recall of 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... on 2014-04-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1651-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-23
Posted: 2014-05-23
Terminated: 2014-11-05
Recalling firm: Kulzer GmbH
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 teeth to receive fixed prosthesis or restorations.
Product code: LBH Varnish, Cavity
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Heraeus Kulzer sent a Voluntary Recall letter dated April 22, 2014 to all affected doctors and supply centers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: 1. Inspect your inventory, both in storage and in use, and identify the lot number on your kits and syringes. Refer to attached images. 2. If you identify any Gluma Desensitizer PowerGel with the aforementioned kit or syringe lot numbers, immediately cease usage of this product and call Technical Services at 1 (574) 299-5409 3. Please advise if you forwarded this product to any other end users. We will need their contact information inClusive of name, address and phone number. For questions regarding this notification, please call our Technical Service team at (574) 299-5409.
Quantity in commerce: 5,112 syringes or 1,278 kits (1 Kit=4 syringes)
Distribution: US Nationwide Distribution in the states of GA, TX, IL, CA, WA, WI, HI, MO, FL, NJ, TN, PA, NY, NC, OH, IN, CT, KY, AZ, NV, IA,
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1651-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1651-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-28	2014-05-22

Product code LBH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)