Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Recalled by Ultradent Products, Inc. Due to Due to a manufacturing issue, red particulates present...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ultradent Products, Inc. directly.
Affected Products
Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for direct and indirect posterior and anterior tooth restorations. Transcend universal composite is radiopaque and available in a range of dentin, enamel, and body shades. It is 79% filled by weight and 60-61% filled by volume and has an average particle size of 0.9 ¿m (by weight) with narrow upper limit particle distribution. Component: N/A
Quantity: 2450
Why Was This Recalled?
Due to a manufacturing issue, red particulates present in the expressed composite.
Where Was This Sold?
This product was distributed to 35 states: AZ, CA, CO, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NY, NC, ND, OH, SC, TN, TX, UT, VT, VA, WV, WI
About Ultradent Products, Inc.
Ultradent Products, Inc. has 23 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report