3M Fast Release Varnish — Class II medical device recall Z-0368-2019
Terminated recall by 3M Company - Health Care Business, reported 2018-11-07, distributed in CA, FL, IN, NV, PA, TN, TX, WA. Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material bein
| Recall number | Z-0368-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | 3M Company - Health Care Business, Saint Paul, MN, United States |
| Recall initiated | 2018-07-06 |
| Classified | 2018-11-01 |
| Reported by FDA | 2018-11-07 |
| Terminated | 2019-02-26 |
| Distributed | CA, FL, IN, NV, PA, TN, TX, WA |
| Reason classes | foreign material |
| UPC / GTIN / UDI-DI | 30605861060661, 50605861060665 |
| Model numbers | 12158M, 70-2014-0568-8 |
Product
3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack, with each package containing 1 0.40 ml varnish and 1 applicator brush. Product is applied to tooth surfaces for sealing dentinal tubules and treatment of hypersensitive teeth.
Reason for recall
Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product.
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-0368-2019. 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.