Carestream Dental CS 3600 Tips Recall: Mirror May Detach and Fall
Carestream Dental recalls CS 36:00 Single Use Normal Tips (Catalog 5941216) due to risk of mirror detachment and falling. All units are affected.
Use caution until it’s fixed
The mirror may become detached and fall from the unit
Contact the company
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. Read more at govinfonow.com/recall/63267-carestream-dental-cs-3600-tips-recall-mirror-may-detach-and.
Source Summary by GovInfoNow · govinfonow.com/recall/63267-carestream-dental-cs-3600-tips-recall-mirror-may-detach-and · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1268-2021
Cite this page
“Carestream Dental CS 3600 Tips Recall: Mirror May Detach and Fall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63267-carestream-dental-cs-3600-tips-recall-mirror-may-detach-and. Based on FDA recall #Z-1268-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1268-2021%22&limit=1).
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
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.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 24 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of WA, MD, WV, NE, SC, NJ, FL, OH, CA, OR, LA, MO, NY, MI, MA, ID, TN, GA, MN, NC, PA, AZ, OK, IN and the country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Florida, Georgia, Idaho, Indiana, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Washington, West Virginia.
Recall timeline
FDA terminated this recall 23 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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.