Approximately 3,100 units of Vit-l-escence and Transcend dental restorative composites have been recalled because a manufacturing issue caused red particulates to be present in the material. These light-cured resin materials are used by dental professionals for tooth restorations. The recall affects specific lot numbers of Vit-l-escence Singles A3, Transcend Econo Kits, and Transcend Universal Body Refill packs sold across 34 U.S. states and several foreign countries. Consumers and dental professionals should identify and stop using the affected materials immediately.
The presence of red particulates in the composite material may compromise the structural integrity or aesthetic quality of dental restorations. If used, these contaminants could lead to improper curing or localized irritation at the restoration site.
Manufacturer Notification
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.