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Ultradent Products Recalls
24 recalls on record · June 27, 2012 to April 8, 2026 · Food & Beverage, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 8, 2026Medical DevicesFDA
Ultradent Products, Inc. recalls Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
Hazard: Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.
September 18, 2024Medical DevicesFDA
Ultradent Products, Inc. recalls Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Sof
Hazard: Due to a manufacturing issue, red particulates present in the expressed composite.
September 18, 2024Medical DevicesFDA
Ultradent Products, Inc. recalls Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- Software Version:
Hazard: Due to a manufacturing issue, red particulates present in the expressed composite.
September 18, 2024Medical DevicesFDA
Ultradent Products, Inc. recalls Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A P
Hazard: Due to a manufacturing issue, red particulates present in the expressed composite.
July 20, 2022Medical DevicesFDA
Ultradent Products, Inc. recalls Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Prime
Hazard: 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.
October 14, 2020Medical DevicesFDA
Ultradent Products, Inc. recalls PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flow
Hazard: Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.
January 9, 2019Medical DevicesFDA
Ultradent Products, Inc. recalls Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Cool Mint: Enamelast 5% Sodium Fluoride
Hazard: Dental varnish has the possibility of having an unpleasant and off flavor.
October 4, 2017Medical DevicesFDA
Ultradent Products, Inc. recalls Ultradent Products, Inc. Paper Points, Size 50 PN #1559, 200 per container, sterile. Product Usage: The product i
Hazard: The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
October 4, 2017Medical DevicesFDA
Ultradent Products, Inc. recalls Ultradent Products, Inc. Paper Points, Size 45 PN #1558, 200 per container, sterile. Product Usage: The product is
Hazard: The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
October 4, 2017Medical DevicesFDA
Ultradent Products, Inc. recalls Ultradent Products, Inc. Paper Points, Size 30 PN #1555, 200 per container, sterile. Product Usage: The product i
Hazard: The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
October 4, 2017Medical DevicesFDA
Ultradent Products, Inc. recalls Ultradent Products, Inc. Paper Points, Size 25 PN #1554, 200 per container, sterile. Product Usage: The product i
Hazard: The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
October 4, 2017Medical DevicesFDA
Ultradent Products, Inc. recalls Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 200 per container, sterile. Product Usage: The product is
Hazard: The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
January 25, 2017Medical DevicesFDA
Ultradent Products, Inc. recalls NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection molded royal blue tips that contain stainles
Hazard: 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.
December 14, 2016Medical DevicesFDA
Ultradent Products, Inc. recalls UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. Product Usage: The UltraSeal XT P
Hazard: 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 UltraSeal XT Plus Clear Refill, PN 565, Lot BD79T.
January 13, 2016Medical DevicesFDA
Ultradent Products, Inc. recalls InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 Product Usage: Inte
Hazard: 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.
December 18, 2013Medical DevicesFDA
Ultradent Products, Inc. recalls Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use
Hazard: Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution.
April 3, 2013Food & BeverageFDA
Ultradent Products, Inc. recalls Opalescence Treswhite Supreme Peach Patient Kit
Hazard: Product was packaged into kits labeled as having a shelf life of 2103-05. The correct shelf life is 2013-05.
March 6, 2013Medical DevicesFDA
Ultradent Products, Inc. recalls Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9%
Hazard: Orthodontic brackets distributed was incorrectly labeled.
February 20, 2013Medical DevicesFDA
Ultradent Products, Inc. recalls Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013,
Hazard: Incorrect packaging of regular set and fast set cartridges.
February 20, 2013Medical DevicesFDA
Ultradent Products, Inc. recalls Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 501
Hazard: Incorrect packaging of regular set and fast set cartridges.
July 11, 2012Food & BeverageFDA
Ultradent Products, Inc. recalls Spearmint Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack. Pa
Hazard: 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-ingredient in the ingredients statement. They are also recalling a single lot of spearmint flavored gum as it was accidentally manufactured with cinnamon flavored product.
July 11, 2012Food & BeverageFDA
Ultradent Products, Inc. recalls Xylishield Dental Care Kit containing 60 pieces of Cinnamon Xylishield gum. The product is packaged in blue and white p
Hazard: 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-ingredient in the ingredients statement.
July 11, 2012Food & BeverageFDA
Ultradent Products, Inc. recalls Cinnamon Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack. Pac
Hazard: 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-ingredient in the ingredients statement.
June 27, 2012Medical DevicesFDA
Ultradent Products, Inc. recalls Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. T
Hazard: 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 professionals for bonding needs in restorative dental procedures.