3M Company - Health Care Business: Medical Device Recall in 2018 - (Recall #: Z-0368-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 6, 2018

Date Posted: November 7, 2018

Recall Number: Z-0368-2019

Event ID: 80730

Reason for Recall:

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

Status: Terminated

Product Quantity: 73 units (200 pack)

Code Information:

Catalogue Code: 12158M, 3M ID Number 70-2014-0568-8, Lot Number BFLSB, Lot # BFLSB, Expiration Date 2020-02, GTIN (consumer primary carton) 30605861060661, GTIN (shipper) 50605861060665

Distribution Pattern:

US distribution to states of: CA, FL, IN, NV, PA, TN, TX and WA.

Voluntary or Mandated:

Voluntary: Firm initiated