CLASS II ONGOING Device recall · Reported 18 Sep 2024 · FDA Enforcement Report
Vit-l-escence Singles A3 recalled by Ultradent Products
Ultradent Products is recalling Vit-l-escence Singles A3, 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-3066-2024
- 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
- Medical Software
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: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A Product Description: Vit-l-escence composite is a light-cured, microhybrid, Bis-GMA esthetic composite restorative material. It is 75% filled by weight, 52% filled by volume with 0.7 ¿m average particle size. Dentin Shades: fluorescent properties to replicate natural dentin. Available in 18 dentin shades. Enamel Shades: opalescent properties to replicate enamel. Available in 16 enamel shades including pearl, translucent, and opaque shades. 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 1203; UDI-DI 00883205106094; Lot Number C1CF7; Expiration Date 04-Aug-2027
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 95175This product is part of a recall event; the main page for the event is Transcend Singles Universal Body (UB) Refill recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Transcend Singles Universal Body (UB) Refill recalled | Ultradent Products | Particulate Matter | 35 states | |
| CLASS II | Transcend Econo Kit (UB) - Singles 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 | Transcend Econo Kit (UB) - Singles recalled by Ultradent Products | Ultradent Products | Particulate Matter | 35 states |
| Device | CLASS II | Transcend Singles Universal Body (UB) Refill recalled | 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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