FDA Medical Device Recalls (openFDA)
Cosmedent, Inc.: Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.
- Recall number
- Z-0741-2018
- Recalling firm
- Cosmedent, Inc.
- Product
- Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.
- Status
- Terminated
- Initiated
- 2017-09-28
- Posted
- not on file
- Terminated
- 2020-10-05
- Reason
- Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.
- Root cause
- Under Investigation by firm
- Action
- Customers were sent recall notification letters on approximately 09/28/2017. The letter identified the affected device and discussed the reason for the recall. Instructions included discontinuing use of the product, and returning it to Cosmedent. The firm will issue a credit or refund for the recalled device.
- Quantity
- 84 units
- Distribution
- Worldwide Distribution -- USA, to the states of IL, LA, MI, PA, and WI; and, to the countries of Australia, Hungary, and Spain.
- Lot, serial or model codes
- SKU #663-103, Lot No. 164222A, Exp. Date 10/31/2019
- 510(k) numbers
- ["K052501"]
- PMA numbers
- not on file
- Product code
- KLE
- Firm FEI
- 1450653
- Firm city
- Chicago
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28