Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2… — Class II medical device recall Z-1651-2014
Terminated recall by Heraeus Kulzer, LLC., reported 2014-05-28, distributed nationwide. The firm discovered that the Gluma Desensitizer Power Gel can be inadvertently extruded from the application s
| Recall number | Z-1651-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heraeus Kulzer, LLC., South Bend, IN, United States |
| Recall initiated | 2014-04-23 |
| Classified | 2014-05-22 |
| Reported by FDA | 2014-05-28 |
| Terminated | 2014-11-05 |
| Distributed | Nationwide (US) |
| Lot numbers | 010103, 42.43.44.45.46.47.48.49 |
| Model numbers | 2015-09, 66043451 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1651-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.