Ultradent Products recalls
Ultradent Products appears in 24 official U.S. recall notices indexed by RecallRadar, most recently on 2026-04-08.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 24 |
|---|---|
| Published | 2012-06-27 to 2026-04-08 |
| By agency | FDA Device (20), FDA Food (4) |
| By classification | Class II (19), Class III (5) |
| By status | terminated (19), ongoing (4), completed (1) |
| Distribution named in notices | AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, US, UT, VA, VT, WA, WI, WV, WY |
Recalls
- Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011
FDA Device · Class II · 2026-04-08 · Ultradent Products
Reason: Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment. - Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A Product Description: Vit…
FDA Device · Class II · 2024-09-18 · Ultradent Products
Reason: Due to a manufacturing issue, red particulates present in the expressed composite. - Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- Software Version: N/A Product Descriptio…
FDA Device · Class II · 2024-09-18 · Ultradent Products
Reason: Due to a manufacturing issue, red particulates present in the expressed composite. - Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A Pro…
FDA Device · Class II · 2024-09-18 · Ultradent Products
Reason: Due to a manufacturing issue, red particulates present in the expressed composite. - Peak Universal Bond Self-Etch Bottle Kit, Part: 4541
FDA Device · Class II · 2022-07-20 · Ultradent Products
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. - PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite
FDA Device · Class II · 2020-10-14 · Ultradent Products
Reason: Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous. - Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 200pk Kit - Co…
FDA Device · Class II · 2019-01-09 · Ultradent Products
Reason: Dental varnish has the possibility of having an unpleasant and off flavor. - Ultradent Products, Inc
FDA Device · Class II · 2017-10-04 · Ultradent Products
Reason: The barcode label was placed underneath the sterile barrier and the product was re-wrapped. - Ultradent Products, Inc
FDA Device · Class II · 2017-10-04 · Ultradent Products
Reason: The barcode label was placed underneath the sterile barrier and the product was re-wrapped. - Ultradent Products, Inc
FDA Device · Class II · 2017-10-04 · Ultradent Products
Reason: The barcode label was placed underneath the sterile barrier and the product was re-wrapped. - Ultradent Products, Inc
FDA Device · Class II · 2017-10-04 · Ultradent Products
Reason: The barcode label was placed underneath the sterile barrier and the product was re-wrapped. - Ultradent Products, Inc
FDA Device · Class II · 2017-10-04 · Ultradent Products
Reason: The barcode label was placed underneath the sterile barrier and the product was re-wrapped. - NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection molded royal blue tips that contain stainless steel 30-gauge can…
FDA Device · Class II · 2017-01-25 · Ultradent Products
Reason: Ultradent Products, Inc. announces a voluntary field action for the NanoTips 30g 20pk, 100pk because the cannula attached to the tip hub may become loose or detach from the blue base that connects to the syringe. - UltraSeal XT Plus Clear Refill
FDA Device · Class II · 2016-12-14 · Ultradent Products
Reason: There was a labeling error with product, UltraSeal XT Plus Clear Refill, Part Number (PN) 565, Lot Number (Lot) BD79T. The package was mislabeled as PQ1, PN 641; while the barcode, IFU and products were labeled for Ultr… - InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 Product Usage: InterGuard is a preventive ai…
FDA Device · Class II · 2016-01-13 · Ultradent Products
Reason: Ultradent is recalling InterGuard 5.5mm Econo Refill, lot#s BC2GN and BC4L7 because product was received from the supplier with the floss tether hole not completely punched through and were distributed. - Opal Orthodontics by Ultradent
FDA Device · Class III · 2013-12-18 · Ultradent Products
Reason: Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution. - Opalescence Treswhite Supreme Peach Patient Kit
FDA Food · Class III · 2013-04-03 · Ultradent Products
Reason: Product was packaged into kits labeled as having a shelf life of 2103-05. The correct shelf life is 2013-05. - Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide
FDA Device · Class III · 2013-03-06 · Ultradent Products
Reason: Orthodontic brackets distributed was incorrectly labeled. - Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used…
FDA Device · Class III · 2013-02-20 · Ultradent Products
Reason: Incorrect packaging of regular set and fast set cartridges. - Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. U…
FDA Device · Class III · 2013-02-20 · Ultradent Products
Reason: Incorrect packaging of regular set and fast set cartridges. - Spearmint Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack
FDA Food · Class II · 2012-07-11 · Ultradent Products
Reason: Ultradent is recalling 36 lots of cinnamon flavored Xylishield gum sold in cartons containing 60 individual pieces as well as within the Xylishield dental care kit due to the omission of the major allergen Soy as a sub-… - Xylishield Dental Care Kit containing 60 pieces of Cinnamon Xylishield gum
FDA Food · Class II · 2012-07-11 · Ultradent Products
Reason: Ultradent is recalling 36 lots of cinnamon flavored Xylishield gum sold in cartons containing 60 individual pieces as well as within the Xylishield dental care kit due to the omission of the major allergen Soy as a sub-… - Cinnamon Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack
FDA Food · Class II · 2012-07-11 · Ultradent Products
Reason: Ultradent is recalling 36 lots of cinnamon flavored Xylishield gum sold in cartons containing 60 individual pieces as well as within the Xylishield dental care kit due to the omission of the major allergen Soy as a sub-… - Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer
FDA Device · Class II · 2012-06-27 · Ultradent Products
Reason: Ultradent is recalling lot B6Z4K of Peak SE Primer as a result of a field complaint, dated May 10, 2012, stating that a syringe of Peak SE Primer was mislabeled as Peak LC Bond Resin. These products are used by Dental p…