Cosmedent, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0741-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.

Product Classification:

Class II

Date Initiated: September 28, 2017

Date Posted: March 7, 2018

Recall Number: Z-0741-2018

Event ID: 78479

Reason for Recall:

Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.

Status: Terminated

Product Quantity: 84 units

Code Information:

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

Distribution Pattern:

Worldwide Distribution -- USA, to the states of IL, LA, MI, PA, and WI; and, to the countries of Australia, Hungary, and Spain.

Voluntary or Mandated:

Voluntary: Firm initiated