Carestream Dental CS 3600 Tips Recall: Mirror May Detach and Fall

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Recalling firmCARESTREAM DENTAL, LLC3625 Cumberland Blvd Se Ste 700, N/A · Atlanta, GA 30339-6406

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Carestream Dental is recalling their CS 3600 Single Use Normal Tips because the mirror could detach and fall from the unit. This poses a potential safety hazard for users.

Why it’s dangerous

The mirror in the tip can become detached during use and fall from the unit. This could cause injury if it strikes someone or damage equipment.

Who’s affected

Dental professionals using Carestream Dental CS 3600 Single Use Normal Tips are most at risk. The product is used for dental impressions and scans.

How to tell if you have this one

Check for Carestream Dental CS 3600 Single Use Normal Tips with catalog number 5941216. All units are affected regardless of lot number.

Brand
Carestream Dental
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Detachment
Inspect the mirror for signs of detachment before use. If detached, stop using the tip immediately.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The mirror may become detached and fall from the unit during use, posing a potential safety hazard.

Is there a specific model or lot number affected?

All units of Carestream Dental CS 3600 Single Use Normal Tips with catalog number 5941216 are affected.

What should I do if the mirror detaches?

Stop using the tip immediately and check for any injuries. Contact Carestream Dental for further assistance.

Take action

Contact Carestream Dental

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

✉️ Open in email

Subject: Recall Z-1268-2021 — Carestream Dental Carestream Dental

Hello,

I own a Carestream Dental that is covered by recall Z-1268-2021 from Carestream Dental.

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-1268-2021 (February 15, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1268-2021 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.

CARESTREAM DENTAL, LLC recalls Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to record the

Use caution until it’s fixed