Cosmedent, Inc. is recalling approximately 7,400 packs of its FlexiCup Composite Finishing & Polishing System (Medium Blue, Six Pack) because the elastomer cup material can crumble during dental procedures. This recall affects the autoclavable aluminum oxide polishing instruments sold worldwide and nationwide in the United States. Consumers should identify if they have the affected blue polishing cups and contact their healthcare provider or the manufacturer immediately regarding the defect.
The elastomer cup material can crumble or break apart during use. This poses a risk of material fragments falling into a patient's mouth or being inhaled or swallowed during a dental finishing and polishing procedure.
Manufacturer Notification and Guidance
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 ยท 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.