Cosmedent FlexiCup (Cosmedent) – Material Crumbling (2023)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Reports were received the elastomer cup material is crumbling.

Recommended Action

Per FDA guidance

The recalling firm issued letters dated 6/28/2023 via USPS Priority Mail on 7/7/2023 or 7/8/2023. The letter explained the reason for recall and requested the consignee immediately examine their inventory and quarantine the affected product. The consignee was to notify their customers of the recall, as well. A response form was enclosed for return via FAX or email to report the amount of product in the consignee's inventory, that the consignee understands the recall instructions, the amount of product being returned, held for return, or destroyed, and whether any adverse events have been associated with the recalled product. As a result of letter delivery issues, the firm recontacted customers on 7/13/2023 via email explaining the problem with the delivery and inserting a link into the email containing the recall letter and response form. The firm also knew on that date who did not open the emails and then called them on 7/13&14/2023, but the content of the call was not provided. On/about 7/21/2023, the firm emailed recall documents to their customers via USPS Priority Mail.