Keystone Bosworth Copaliner Cavity Varnish — Class II medical device recall Z-2579-2023
Ongoing recall by Keystone Industries, reported 2023-09-20, distributed nationwide. A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and
| Recall number | Z-2579-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Keystone Industries, Gibbstown, NJ, United States |
| Recall initiated | 2023-07-21 |
| Classified | 2023-09-12 |
| Reported by FDA | 2023-09-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | BD, CA, DE, GB |
| Quantity | 337 units |
| Reason classes | labeling |
| Lot numbers | NB7972 |
| Model numbers | 0921526 |
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
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2579-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.