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Lower risk Medical device recall · FDA · Published July 6, 2018

3M Fast Release Varnish Mint Flavor Recall: Unpleasant Flavor Due to Manufacturing Error

3M recalls 200-pack of Mint Flavor Fast Release Varnish due to an unpleasant flavor caused by a manufacturing error. This Rx-only product may contain extraneous material affecting taste.

🇺🇸 FDA recall #Z-0368-2019Medical device3M ›
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Recalling firm3M Company - Health Care Business3m Center 2510 Conway Ave , B# 275-5-W-6 · Saint Paul, MN 55144-0001
✎ GovInfoNow plain-language explainer

What happened, in plain English

3M is recalling 200 packs of Mint Flavor Fast Release Varn: the product has an unpleasant flavor because of a manufacturing error that introduced extra material. This affects people using it for sensitive teeth treatment. Read more at govinfonow.com/recall/70658-3m-fast-release-varnish-mint-flavor-recall-unpleasant-flavor-due.

Source Summary by GovInfoNow · govinfonow.com/recall/70658-3m-fast-release-varnish-mint-flavor-recall-unpleasant-flavor-due · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0368-2019

Cite this page

“3M Fast Release Varnish Mint Flavor Recall: Unpleasant Flavor Due to Manufacturing Error.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70658-3m-fast-release-varnish-mint-flavor-recall-unpleasant-flavor-due. Based on FDA recall #Z-0368-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0368-2019%22&limit=1).

Why it’s dangerous

The product contains an extra material from a manufacturing error that makes it taste unpleasant. This does not cause injury or health risks but affects the taste experience.

Who’s affected

People with prescriptions for sensitive teeth who use this specific 3M Fast Release Varnish product. Those who have the 200-pack with mint flavor are most at risk.

How to tell if you have this one

Look for the 3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single-use product in a 200-pack. The package contains 0.40 ml varnish and one applicator brush.

  • Brand
    3M
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the product has the 200-pack with mint flavor and Rx-only label as described in the recall.

Where it went and when

Where it was distributed

Distributed in 8 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: yesWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: yesNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: yesINOhio: not listedOHPennsylvania: yesPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: yesTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “US distribution to states of: CA, FL, IN, NV, PA, TN, TX and WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Florida, Indiana, Nevada, Pennsylvania, Tennessee, Texas, Washington.

Recall timeline

FDA terminated this recall 8 months after the firm started it.

1. Firm started the recall: Jul 6, 201812. FDA classified it Class II: Nov 1, 201823. Published in FDA’s Enforcement Report: Nov 7, 201834. FDA terminated the recall: Feb 26, 2019420182019
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

What should I do with the product?

The recall does not require stopping use or returning the product; it only addresses the taste issue.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0368-2019 (July 6, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0368-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA