FDAClass IISeptember 18, 2024

Brand Name: Transcend Product Name: Transcend Singles recall: Particulate Matter

Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A Product…

Why was Brand Name: Transcend Product Name: Transcend Singles recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Code: Model No 4757; UDI-DI 00883205028334; Lot Number C15C2; Expiration Date 31-May-2026

Product
Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A Product…
Recalling firm
Ultradent Products, Inc.
Quantity
2450
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
Recall date
September 18, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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