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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68223

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
April 23, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Heraeus Kulzer, LLC.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1651-2014
Recall number
Z-1651-2014
Initiated
April 23, 2014
Classification
Class II
Status
Terminated
Recalling firm
Heraeus Kulzer, LLC.
Quantity
5,112 syringes or 1,278 kits (1 Kit=4 syringes)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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 pattern

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,