CLASS II Device recall · Reported 7 Nov 2018 · FDA Enforcement Report
3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor recalled
3M Company - Health Care Business is recalling 3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, distributed in 8 states. The recall was initiated on 6 Jul 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0368-2019
- FDA event ID
- 80730
- Recalling firm
- 3M Company - Health Care Business, Saint Paul, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Jul 2018
- FDA classified
- 1 Nov 2018
- Reported
- 7 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 6 Jul 2018 | Recall initiated by company | |
| 1 Nov 2018 | Classified by FDA | +118 days |
| 7 Nov 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
US distribution to states of: CA, FL, IN, NV, PA, TN, TX and WA.
CaliforniaFloridaIndianaNevadaPennsylvaniaTennesseeTexasWashington
Questions about this recall
Why was it recalled?
Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product.
Which lots are affected?
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
Where was it sold?
US distribution to states of: CA, FL, IN, NV, PA, TN, TX and WA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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