Reported Nov 8, 2023 · Ongoing

Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument,…

Cosmedent, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cosmedent, Inc. · 4646 N Ravenswood Ave · Chicago, IL · 60640-4510

Is this the product you have?

  • Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, Rx.
Lot codes and dates
    • Lot numbers 464948
    • 465769
    • 467512
    • 470596
    • 477493
    • 478610
    • 479776
    • 482382
    • 484262
    • and 484781
    • UDI-DI D77940310111
Amount recalled
7,400 packs of 6

Where it was sold

  • Nationwide

Why it was recalled

Reports were received the elastomer cup material is crumbling.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:02 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.