The Recall Desk
HighFDA (Devices)·Z-0741-2018·Announced 2018-03-07

Cosmedent Etching Gel Recalled Due to Syringe Tip Detachment Risk

Cosmedent, Inc. is recalling 84 units of Etching Gel because the syringe tips may detach during use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where the syringe tip may detach during use, but the source text does not report any injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

Cosmedent, Inc. is recalling 84 units of Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid. The product is packaged in 3g syringes and is used for etching enamel and dentin. The specific lot number is 164222A, with an expiration date of 10/31/2019.

The recall is being conducted because the product is packaged in a syringe that is not a Luer Lock syringe. This design flaw creates a risk that the tip may come off when the material is being expressed. The affected units were distributed worldwide, including in the United States (Illinois, Louisiana, Michigan, Pennsylvania, and Wisconsin) and in Australia, Hungary, and Spain.

Healthcare professionals and patients who have this specific lot of Etching Gel should stop using it immediately. They should contact Cosmedent, Inc. for instructions on how to return the product for a refund or replacement.

The recalled product

Product
Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.
Manufacturer
Cosmedent, Inc.
Category
Medical Device — Dental Supplies
Hazard
Affected units
84

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • SKU #663-103
  • Lot No. 164222A
  • Exp. Date 10/31/2019

Distribution

Distributed in 5 states:

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Same hazard · tip detachment

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