Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 28, 2014
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.
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Heraeus Kulzer, LLC. recalled Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device.… - a moderate-severity action.
Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device.… was recalled by Heraeus Kulzer, LLC. in May 28, 2014. Reason: The firm discovered that the Gluma Desensitizer Power Gel can be inadvertently extruded from the application …. Check the official notice for the remedy. Verify recall #Z-1651-2014 with the FDA Devices before acting.
The recall
Heraeus Kulzer, LLC. issued this moderate-severity FDA Devices recall-The firm discovered that the Gluma Desensitizer Power Gel can be inadvertently extruded from the application ….
- Moderate
- severity level
- Class II
- classification
- May 28, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1651-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1651-2014) was formally reported on May 28, 2014, with the manufacturer initiating the action on April 23, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Heraeus Kulzer, LLC. is listed as the recalling firm, operating out of South Bend, IN. Federal records list the affected scope as 5,112 syringes or 1,278 kits (1 Kit=4 syringes).
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: 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,. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
5,112 syringes or 1,278 kits (1 Kit=4 syringes)
Related Recalls
6
3 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1651-2014 |
| Date reported | May 28, 2014 |
| Date initiated | April 23, 2014 |
| Recalling firm | Heraeus Kulzer, LLC. |
| Firm location | South Bend, IN |
| Affected scope | 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, |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1651-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Heraeus Kulzer, LLC.. Units affected: 5,112 syringes or 1,278 kits (1 Kit=4 syringes).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 28, 2014. Severity: Moderate. Recall number: Z-1651-2014.
Where was the recalled product distributed? ▼
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,.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1651-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 28, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.