Lower risk Medical device recall · FDA · Published July 21, 2023

Keystone Bosworth Copaliner Varnish Recall: Wrong Solvent Packaged

Keystone Industries recalls Copaliner Varnish (0921526) due to accidental inclusion of Copaliner Solvent in packaging. This could cause improper use in dental procedures.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2579-2023Medical device Keystone Industries ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmKeystone Industries480 S Democrat Rd · Gibbstown, NJ 08027-1239

✎ GovInfoNow plain-language explainer

Keystone Industries is recalling their Copal: 0921526 Varnish product because it was mistakenly packaged with Copaliner Solvent instead of Varnish. This mix-up could lead to improper dental sealant application if used without knowing the solvent is present. Read more at govinfonow.com/recall/57620-keystone-bosworth-copaliner-varnish-recall-wrong-solvent-packaged.

Source Summary by GovInfoNow · govinfonow.com/recall/57620-keystone-bosworth-copaliner-varnish-recall-wrong-solvent-packaged · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2579-2023

Cite this page

“Keystone Bosworth Copaliner Varnish Recall: Wrong Solvent Packaged.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/57620-keystone-bosworth-copaliner-varnish-recall-wrong-solvent-packaged. Based on FDA recall #Z-2579-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2579-2023%22&limit=1).

Keystone Industries recalled Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml) on July 21, 2023, after the FDA announced that a bottle of Copaliner Solvent was inadvertently packaged in boxes labeled as varnish. The Food and Drug Administration issued the recall for Item No. 0921526.

How to tell if you have it

Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)
Item No. 0921526
Lot No. NB7972
UDI: +H66809215261/$$3241027NB7972%

The hazard

A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as such. The varnish is intended to provide a marginal seal between the dentin and amalgam.

Context

GovInfoNow's records show Keystone Industries has five other recalls on record since April 10, 2023. Other recent recalls of similar products include Henry Schein Recalls Structur 2 SC Resin Cartridge Refills with Incorrect Packaging (July 9, 2026) and Henry Schein Grandio Dental Capsules Recall: Incorrect Packaging Hazard (July 9, 2026).

How to tell if you have this one

Check for the product label 'Copaliner Varnish (0921526)' with the UDI code *+H66809215261/$$3241027NB7972%* and lot number NB7972. The product was sold as a 0.5oz (14 ml) bottle.

Brand
Keystone Industries
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the UDI code *+H66809215261/$$3241027NB7972%* and lot number NB7972 on the bottle.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Canada, Bangladesh, Germany, UK.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 2 months after the firm started it.

Jul 21, 2023Firm started the recall
Sep 12, 2023FDA classified it Class II
Sep 20, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Keystone Industries recalls

Link to this recall

<a href="https://govinfonow.com/recall/57620-keystone-bosworth-copaliner-varnish-recall-wrong-solvent-packaged">Keystone Bosworth Copaliner Varnish Recall: Wrong Solvent Packaged (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2579-2023 (July 21, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2579-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.