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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall involves contamination (red particulates) in a dental composite used directly in the oral cavity. Although no illnesses or injuries have been reported, this qualifies as a risk-of-harm product where manufacturing defects could compromise restoration safety and integrity.
Plain-English summary
Ultradent Products, Inc. is recalling the Transcend Econo Kit (UB) - Singles, a light-cured dental composite resin used for direct and indirect tooth restorations (Catalog/Model Number 4817). The affected units include Lot Number C1464 with expiration date June 30, 2026 (UDI-DI 00883205033680). Approximately 560 units were distributed.
The recall was issued due to a manufacturing issue that resulted in red particulates present in the expressed composite material.
The affected product was distributed to dental professionals in 34 U.S. states and to practitioners in Netherlands, Germany, Switzerland, Czech Republic, France, and Spain. This is classified as an FDA Class II medical device recall (recall number Z-3067-2024).
The recalled product
- 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…
- Manufacturer
- Ultradent Products, Inc.
- Affected units
- 560
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot Code: Model No 4817
- UDI-DI 00883205033680
- Lot Number C1464
- Expiration Date 30-Jun-2026
Distribution
Part of a larger recall action
This product is one of 3 recalled by Ultradent Products, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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