Keystone Industries 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 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Keystone Industries
Lot Codes / Batch Numbers
UDI: *+H66809215261/$$3241027NB7972%* Lot No. NB7972
Products Sold
UDI: *+H66809215261/$$3241027NB7972%* Lot No. NB7972
Keystone Industries is recalling Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between due to A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526).. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526).
Recommended Action
Per FDA guidance
Keystone Industries issued Urgent Medical Device Recall Letter to Distributors and End Users via email on July 21, 2023. Letter states reason for recall, health risk and action to take: Wholesale: IMMEDIATE ACTIONS TO BE TAKEN 1.Review product inventory and quarantine all affected product on hand.2.Implement appropriate control measures to quarantine any shipments which may be in transit.3.Review distribution records and identify all customers who were shipped the affected product lot. (If no products were distributed and all units are accounted for skip step 4 and move to step 5.)4.Send End User Recall Notification provided to you with this notification to all identified customers that received product, instructing them to follow the directions on the letter to return all affected products to Keystone Industries.5.Return all affected products in your inventory to Keystone Industries by requesting a Return Materials Authorization (RMA) number at credits@keystoneind.com. Complete the attached Acknowledgement of Medical Device Recall Form and return within 5 days of receiving this notice. Email the completed form to amcclure@keystoneind.com and tschwear@keystoneind.com. End-User: 1. Review product inventory on hand. 2. Complete the attached Recall Acknowledgement Form and return within 5 days of receiving this notice. Email the completed form to amcclure@keystoneind.com and tschwear@keystoneind.com. 3. Follow instructions on the form to return product and receive credit. If you have any questions after reviewing this notice, please email using the address below or call Gloria Zuclich at 856-663-4700 Ext 7252 between 8:00 am and 5:00 pm EST, Monday through Friday,
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026