3M Unitek Corporation: Medical Device Recall in 2025 - (Recall #: Z-0797-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit box) Transbond Plus Self Etching Primer is an orthodontic all-in-one etchant and primer that is used in the bonding process of orthodontic appliances to teeth.

Product Classification:

Class II

Date Initiated: November 26, 2024

Date Posted: January 8, 2025

Recall Number: Z-0797-2025

Event ID: 95841

Reason for Recall:

Due to an increase of complaints for bracket bond failures and skin irritation or blistering.

Status: Ongoing

Product Quantity: 5,873 boxes (380,180 individual L-pops)

Code Information:

Product Number: 712-090 UDI-DI code: 00652221109170 Lot Numbers: 11093917 11106533 11120254 11153742 11155372 11173412 Product Number: 712-091 UDI-DI code: 00652221109187 Lot Numbers: 11165780 11165793

Distribution Pattern:

Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of : Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican, Republic, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Hong Kong, Japan, Korea, Latvia, Lithuania, Malaysia, Mexico, Netherland, New Zealand, Norway, Poland, Romania, Singapore, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, and the United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated