# FDA recall Z-0797-2025

> **3M Unitek Corporation** · Class II · device recall initiated 2024-11-26.

## Product

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.

## Reason for recall

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

## Distribution

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.

## Key facts

- **Recall number:** Z-0797-2025
- **Recalling firm:** 3M Unitek Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-26
- **Report date:** 2025-01-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Monrovia, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0797-2025

## Citation

> AI Analytics. FDA recall Z-0797-2025. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0797-2025. Source: US FDA. Licensed CC0.

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