Brand Name: Transcend Product Name: Transcend Econo Kit — Class II medical device recall Z-3067-2024
Ongoing recall by Ultradent Products, Inc., reported 2024-09-18, distributed in AZ, CA, CO, FL, GA, HI, IA, ID…. Due to a manufacturing issue, red particulates present in the expressed composite.
| Recall number | Z-3067-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ultradent Products, Inc., South Jordan, UT, United States |
| Recall initiated | 2024-08-02 |
| Classified | 2024-09-06 |
| Reported by FDA | 2024-09-18 |
| Distributed | 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 |
| Quantity | 560 |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00883205033680 |
| Lot numbers | C1464 |
| Model numbers | 4817 |
| Expiration dates | 2026-06-30 |
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 indirect posterior and anterior tooth restorations. Transcend universal composite is radiopaque and available in a range of dentin, enamel, and body shades. It is 79% filled by weight and 60-61% filled by volume and has an average particle size of 0.9 ¿m (by weight) with narrow upper limit particle distribution. Component: N/A
Reason for recall
Due to a manufacturing issue, red particulates present in the expressed composite.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3067-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.