The Recall Desk

FDA (Devices) recall action 95175

Ultradent Products, Inc. recalled 3 products on 2024-09-18

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2024-09-18
Critical
0
Units
3,100

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2024-09-18

    FDA Recalls Transcend Dental Composite Material Due to Manufacturing Defect

    Ultradent Products is recalling Transcend Singles Universal Body dental composite resin due to red particulates found during manufacturing. The recall affects approximately 2,450 units distributed in the US and several foreign countries.

    Product
    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 d
    Category
    Distribution
    35 states
  • HighFDA (Devices)··2024-09-18

    Dental Composite Resin Recall Due to Red Particulate Contamination

    Ultradent Products recalls Transcend Econo Kit dental composite due to red particulates in the material from a manufacturing issue. Affected lot C1464 was distributed to dental professionals in 34 U.S. states and internationally.

    Product
    Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- 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 indir
    Category
    Distribution
    35 states
  • ModerateFDA (Devices)··2024-09-18

    Ultradent Recalls Vit-l-escence Composite Due to Red Particulates

    Ultradent is recalling Vit-l-escence Singles A3 composite restorative material because a manufacturing issue resulted in red particulates being present in the expressed composite.

    Product
    Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A Product Description: Vit-l-escence composite is a light-cured, microhybrid, Bis-GMA esthetic composite restorative material. It is 75% filled by weight, 52% fi
    Category
    Distribution
    34 states