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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices

3M Unitek Transbond Plus Primer Recalled for Bracket Failure and Skin Irritation

Agency Publication Date: January 2, 2025
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Summary

3M Unitek Corporation is recalling 5,873 boxes (comprising 380,180 individual L-pops) of its Transbond Plus Self-Etching Primer. This recall was initiated due to an increase in reports that the primer fails to bond orthodontic brackets properly to teeth and may cause skin irritation or blistering. The recall affects both the 100-unit and 20-unit packaging configurations used by dental professionals.

Risk

The primer may cause chemical-like skin irritation and blistering upon contact with the skin or oral tissue. Additionally, failures in bracket bonding can disrupt orthodontic treatment and require additional dental procedures to correct. There has been an increase in complaints regarding these issues.

What You Should Do

  1. The recalled products are 3M Unitek Transbond Plus Self-Etching Primer sold in 100-unit boxes (Ref 712-090) and 20-unit boxes (Ref 712-091).
  2. To identify if your supply is affected, check the lot number printed on the product packaging. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product immediately. Contact 3M Unitek Corporation or your authorized dental distributor to arrange for the return, replacement, or correction of your inventory.
  4. Call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for more information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: 3M Unitek Transbond Plus Self-Etching Primer (100 unit box)
Variants: 100 unit box, L-pops
Model / REF:
712-090
Lot Numbers:
11093917
11106533
11120254
11153742
11155372
11173412
UDI:
00652221109170

Recall #: Z-0797-2025

Product: 3M Unitek Transbond Plus Self-Etching Primer (20 unit box)
Variants: 20 unit box, L-pops
Model / REF:
712-091
Lot Numbers:
11165780
11165793
UDI:
00652221109187

Recall #: Z-0797-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95841
Status: Active
Manufacturer: 3M Unitek Corporation
Sold By: Authorized dental distributors
Manufactured In: United States
Units Affected: 5,873 boxes (380,180 individual L-pops)
Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.