Class II — 3M Company - Health Care Business
| Recalling firm | 3M COMPANY |
|---|---|
| Registered facility | View this company's 13 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product. |
| 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. |
| Quantity | 73 units (200 pack) |
| Distribution | US distribution to states of: CA, FL, IN, NV, PA, TN, TX and WA. |
| Initiated | 2018-07-06 |
| Classified | 2018-11-01 |
| Terminated | 2019-02-26 |
| Recall number | Z-0368-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — 3M Company - Health Care Business (Z-0368-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80730/
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