South Jordan, UT, United States
Ultradent Products, Inc. recalls
5 recalls recorded since 2018, most recently on 28 January 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)2
Terminated or completed3
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 28 January 2026
- Reason
- Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.
- Distribution
- US: MA, WI, ME, AL, NY, MN, CA, KY, IL, WY, WA, OH, PR, CT, OR, NJ, MI, NC, HI, PA, NE, TX, UT, NV, LA, VA, MO, FL, AZ, WV, IA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1689-2026
- Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
Ongoing Class II Medical devices
- Recall started
- 2 August 2024
- Reason
- Due to a manufacturing issue, red particulates present in the expressed composite.
- Distribution
- 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
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3068-2024, Z-3067-2024, Z-3066-2024
- 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
- 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 composit
- 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 composit
Completed Class II Medical devices
- Recall started
- 1 June 2022
- Reason
- SE primer may be missing some or all of the resin portion of the chemistry. The absence of resin may impact bond strength and restoration while using the primer.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of Florida, Michigan, Nevada, Washington, Colorado, Virginia, Puerto Rico, Wisconsin, Iowa, Tennessee, Arkansas, Minnesota, Wyoming, Maine and the countries of Kuwait, Italy, France, Canada, Spain, Malaysia, Russia, Greece.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1368-2022
- Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Primer 4pk Refill, Part: 5135; Peak Universal Bond Sample SE, Part: S4554. For use in light-curing denta
Terminated Class II Medical devices
- Recall started
- 31 August 2020
- Terminated
- 18 October 2021
- Reason
- Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, KS, IN, LA, MA, MD, ME, MI, MT, NC, NJ, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VT, WA, and WI. The countries of Australia, Germany Japan and Mongolia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0053-2021
- PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1¿m average particle size with narrow upper limit particle distri
Terminated Class II Medical devices
- Recall started
- 12 July 2018
- Terminated
- 19 February 2019
- Reason
- Dental varnish has the possibility of having an unpleasant and off flavor.
- Distribution
- Worldwide Distribution - US Nationwide: AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY OUS: Germany, Italy, Malaysia, and Poland
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0690-2019
- Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 200pk Kit - Cool Mint REF/UP 4352 Rx CONTENTS: 200 x 0.4 ml Unit Dose Label Ena
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.