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.
What this means for you
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: FDA Class II device recall for a manufacturing defect in a dental composite material intended for oral use. Although no illnesses or injuries are reported in the source, the presence of red particulates in a material used inside the mouth constitutes a risk-of-harm product where injury has not yet been reported, per the severity rubric.
Plain-English summary
Ultradent Products, Inc. is recalling Transcend Singles Universal Body (UB) Refill 10pk, a light-cured dental composite resin used for posterior and anterior tooth restorations.
The product contains a manufacturing defect resulting in red particulates present in the expressed composite material. The affected lot is Model 4757 with Lot Number C15C2 and expiration date May 31, 2026.
Approximately 2,450 units were distributed across the United States (including Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin, and West Virginia) and foreign markets (Netherlands, Germany, Switzerland, Czech Republic, France, and Spain).
Dental professionals and patients should discontinue use of the affected lot and contact Ultradent Products, Inc. for replacement or refund. Users who have experienced any complications should consult their dentist.
The recalled product
- 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
- Manufacturer
- Ultradent Products, Inc.
- Hazard
- manufacturing-defect
- foreign-particulates
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 4757
- UDI-DI 00883205028334
- Lot Number C15C2
- Expiration Date 31-May-2026
Distribution
Distributed in 35 states:
- AZ
- CA
- CO
- DE
- 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
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