Keystone Industries: Medical Device Recall in 2023 - (Recall #: Z-2579-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amalgam which helps to protect against penetration of amalgam into the dentina Item No. 0921526

Product Classification:

Class II

Date Initiated: July 21, 2023

Date Posted: September 20, 2023

Recall Number: Z-2579-2023

Event ID: 92851

Reason for Recall:

A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526).

Status: Ongoing

Product Quantity: 337 units

Code Information:

UDI: *+H66809215261/$$3241027NB7972%* Lot No. NB7972

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Canada, Bangladesh, Germany, UK.

Voluntary or Mandated:

Voluntary: Firm initiated