Cosmedent Etching Gel Recall: Syringe Tip May Detach During Use
Cosmedent recalls 3g Etching Gel with non-Luer Lock syringes that may detach during use, posing a risk of injury. Affected units include SKU #663-103, Lot 164222A, expiring 10/31/2019.
Use caution until it’s fixed
Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.
Contact the company
What happened, in plain English
Cosmedent is recalling its 3g Etching Gel for dental use because the syringe may detach during use, potentially causing injury. This recall affects products sold with non-Luer Lock syringes. Read more at govinfonow.com/recall/72933-cosmedent-etching-gel-recall-syringe-tip-may-detach-during-use.
Source Summary by GovInfoNow · govinfonow.com/recall/72933-cosmedent-etching-gel-recall-syringe-tip-may-detach-during-use · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0741-2018
Cite this page
“Cosmedent Etching Gel Recall: Syringe Tip May Detach During Use.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72933-cosmedent-etching-gel-recall-syringe-tip-may-detach-during-use. Based on FDA recall #Z-0741-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0741-2018%22&limit=1).
Why it’s dangerous
The gel is packaged in syringes that are not properly secured Luer Lock syringes. When the gel is expressed, the syringe tip may detach, creating a risk of injury from the detached part.
Who’s affected
Dentists and dental professionals using Cosmedent's Etching Gel for enamel and dentin preparation are most at risk. The recall applies to specific product SKUs and lots.
How to tell if you have this one
Check for the product name 'Cosmedent Etching Gel', 3g, 37% Phosphoric Acid, Rx only. Affected units have SKU #663-103 and Lot No. 164222A, expiring 10/31/2019.
- Brand
Cosmedent- Category
Medical device
What to do — step by step
Check Syringe Type
Ensure the syringe is a Luer Lock type; non-Luer Lock syringes may detach during use.
Where it went and when
Where it was distributed
Distributed in 5 states, and outside the U.S.
FDA distribution: “Worldwide Distribution -- USA, to the states of IL, LA, MI, PA, and WI; and, to the countries of Australia, Hungary, and Spain.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Illinois, Louisiana, Michigan, Pennsylvania, Wisconsin.
Recall timeline
FDA terminated this recall 3 years 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.
Questions people ask
How long is the product expected to last?
The product expires 10/31/2019, but the recall applies to all units with the specified SKU and lot number.
Similar recalls
Latest medical device recalls
Keep exploring
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-0741-2018 (September 28, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0741-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 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.