Cosmedent, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0211-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, Rx.

Product Classification:

Class II

Date Initiated: July 20, 2023

Date Posted: November 8, 2023

Recall Number: Z-0211-2024

Event ID: 92812

Reason for Recall:

Reports were received the elastomer cup material is crumbling.

Status: Ongoing

Product Quantity: 7,400 packs of 6

Code Information:

Lot numbers 464948, 465769, 467512, 470596, 477493, 478610, 479776, 482382, 484262, and 484781; UDI-DI D77940310111.

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Australia, Colombia, Denmark Ecuador, Estonia, Greece, Hungary, Iran, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Paraguay, Philippines, Spain, Sweden, UAE, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated