Ultradent recalls Transcend Singles Universal Body (UB) Refill 10pk (model 4757) due to red particulates in the composite material that could cause injury during dental procedures.
Due to a manufacturing issue, red particulates present in the expressed composite.
Ultradent recalls Transcend Singles Universal Body (UB) Refill 10pk products because they contain red particulates from a manufacturing issue. This could lead to injury if used in dental procedures, as the particles might cause irritation or damage to the mouth.
The composite material contains red particulates due to a manufacturing issue. These particles could cause irritation or damage to the mouth during dental procedures, but the risk is not severe enough to cause serious injury in normal use.
Dental professionals using Transcend Singles Universal Body (UB) Refill 10pk products for dental restorations are most at risk. Patients receiving dental work with these products may also be affected.
Look for Transcend Singles Universal Body (UB) Refill 10pk products with model number 4757. These were sold starting from the manufacturer's production date until May 31, 2026.
Verify the model number on the product label to confirm it is 4757.
The product contains red particulates that could cause irritation during dental procedures, but it is not immediately dangerous. Dental professionals should check for the issue before use.
The recall does not specify a remedy, so you can continue using it if you check for the model number 4757. However, contact Ultradent for further guidance.
The recall was issued by Ultradent Products, Inc. for products sold from the manufacturer's production date until May 31, 2026.
We’ve drafted a message you can send Transcend to request your refund or repair — edit it as you like.
Subject: Recall Z-3068-2024 — Transcend Transcend Hello, I own a Transcend that is covered by recall Z-3068-2024 from Transcend. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.