ProductGuru
AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

[Recalled] 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 co

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductBrand 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 p
Brand / manufacturerUltradent Products, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-3068-2024
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date02 August 2024
EAN / barcode00883205028334

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Due to a manufacturing issue, red particulates present in the expressed composite.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Ultradent Products, Inc.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

Shop Recalled Brand Name Transcend
Search on Amazon ›Find on eBay ›
As an Amazon Associate and eBay Partner, we may earn from qualifying purchases.
Related articles

Explore by topic

Looking up a product? Use ProductGuru — free barcode & product database with 35M+ products. Search by EAN / UPC barcode.
Was this page helpful?