CLASS II ONGOING Device recall · Reported 18 Sep 2024 · FDA Enforcement Report
Transcend Singles Universal Body (UB) Refill recalled
Ultradent Products is recalling Transcend Singles Universal Body (UB) Refill, distributed in 35 states. The recall was initiated on 2 Aug 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3068-2024
- FDA event ID
- 95175
- Recalling firm
- Ultradent Products, South Jordan, UT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Aug 2024
- FDA classified
- 6 Sep 2024
- Reported
- 18 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Masks, Gloves & PPE
Timeline
| 2 Aug 2024 | Recall initiated by company | |
| 6 Sep 2024 | Classified by FDA | +35 days |
| 18 Sep 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to a manufacturing issue, red particulates present in the expressed composite.
Product as listed by the FDA
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 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
Where it was distributed
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
ArizonaCaliforniaColoradoDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippi
Questions about this recall
Why was it recalled?
Due to a manufacturing issue, red particulates present in the expressed composite.
Which lots are affected?
Lot Code: Model No 4757; UDI-DI 00883205028334; Lot Number C15C2; Expiration Date 31-May-2026
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 95175| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Transcend Econo Kit (UB) - Singles recalled by Ultradent Products | Ultradent Products | Particulate Matter | 35 states | |
| CLASS II | Vit-l-escence Singles A3 recalled by Ultradent Products | Ultradent Products | Particulate Matter | 35 states |
More recalls from Ultradent Products
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Jiffy Original Composite Polisher Cups (Coarse) recalled | Ultradent Products | Device Malfunction | 31 states |
| Device | CLASS II | Vit-l-escence Singles A3 recalled by Ultradent Products | Ultradent Products | Particulate Matter | 35 states |
| Device | CLASS II | Transcend Econo Kit (UB) - Singles recalled by Ultradent Products | Ultradent Products | Particulate Matter | 35 states |
| Device | CLASS II | Peak Universal Bond Self-Etch Bottle Kit, Part recalled | Ultradent Products | Other | Nationwide |
| Device | CLASS II | PermaFlo Flowable Composite recalled by Ultradent Products | Ultradent Products | Other | Nationwide |
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| Device | CLASS II | Opportunity Pro recalled by American Nitrile Operations | American Nitrile Operations | Device Malfunction | Nationwide |
| Device | CLASS II | Opportunity Flex recalled by American Nitrile Operations | American Nitrile Operations | Device Malfunction | Nationwide |
| Device | CLASS II | Performance Pro recalled by American Nitrile Operations | American Nitrile Operations | Device Malfunction | Nationwide |
| Device | CLASS II | P28 Phanton Intramedullary Nail System recalled by Paragon 28 | Paragon 28 | Sterility | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray | Device Malfunction | Nationwide |