Cosmedent FlexiCup Crumbling Cup Hazard - Recall Details

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Recalling firmCosmedent, Inc.4646 N Ravenswood Ave, N/A · Chicago, IL 60640-4510

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Cosmedent is recalling its FlexiCup Composite Finishing & Polishing System because the elastomer cup material is crumbling. This could lead to injury if the cup breaks during use.

Why it’s dangerous

The elastomer cup material is crumbling, which could break during use. If the cup breaks, it may cause injury to the user or the patient.

Who’s affected

Dentists and dental technicians who use the Cosmedent FlexiCup system are affected. Those with the specific lot numbers or reference codes listed are most at risk.

How to tell if you have this one

Check for the product name 'Cosmedent FlexiCup Composite Finishing & Polishing System', six-pack, medium (blue) cups. Look for lot numbers 464948, 465769, 467512, 470596, 477493, 478610, 479776, 482382, 484262, or 484781.

Brand
Cosmedent
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop Using Immediately
Discontinue use of the affected FlexiCup cups to prevent potential injury from crumbling material.

✎ GovInfoNow

Questions people ask

What is the specific hazard with the Cosmedent FlexiCup?

The elastomer cup material is crumbling, which could break during use and cause injury.

Which lot numbers are affected?

Lot numbers 464948, 465769, 467512, 470596, 477493, 478610, 479776, 482382, 484262, and 484781.

How do I know if I have the recalled product?

Check for the product name 'Cosmedent FlexiCup Composite Finishing & Polishing System', six-pack, medium (blue) cups with the listed lot numbers.

Take action

Contact Cosmedent

We’ve drafted a message you can send Cosmedent to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0211-2024 — Cosmedent Cosmedent

Hello,

I own a Cosmedent that is covered by recall Z-0211-2024 from Cosmedent.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0211-2024 (July 20, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0211-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

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Use caution until it’s fixed