Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

3M Fast Release Varnish Recalled by 3M Company - Health Care Business Due to Product has an unpleasant flavor due to a...

Date: July 6, 2018
Company: 3M Company - Health Care Business
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact 3M Company - Health Care Business directly.

Affected Products

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)

Why Was This Recalled?

Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product.

Where Was This Sold?

This product was distributed to 8 states: CA, FL, IN, NV, PA, TN, TX, WA

Affected (8 states)Not affected

About 3M Company - Health Care Business

3M Company - Health Care Business has 40 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report