Ultradent Products, Inc.: Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A Product Description: Transcend univers

Hazard

Due to a manufacturing issue, red particulates present in the expressed composite.

Details from the source

Reason for recall: Due to a manufacturing issue, red particulates present in the expressed composite. Distribution: US: AZ, CA,CO,FL,GA,HI, IA, ID,IL,IN,KS,KY,LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, SC, TN, TX, UT, VA, VT, WI, WV Foreign: NL, DE, CH, CZ, FR, ES Quantity: 2450 Lot/code info: Lot Code: Model No 4757; UDI-DI 00883205028334; Lot Number C15C2; Expiration Date 31-May-2026

UPC codes

00883205028334

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.