The Recall Desk

Manufacturer

Ultradent Products, Inc.

24 recalls in our database name Ultradent Products, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
24
Critical
0
Severe
0
Most recent
2026-04-08

Of the 24 recalls from Ultradent Products, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

Which agencies issued them

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–24 of 24

  • HighFDA (Devices)·Z-1689-2026·2026-04-08

    Jiffy composite polisher cups may crumble and break apart easily

    Ultradent Products is recalling one lot of Jiffy Original Composite Polisher Cups because the cups may crumble and break apart easily, which could delay patient treatment.

    Product
    Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-3068-2024·2024-09-18

    FDA Recalls Transcend Dental Composite Material Due to Manufacturing Defect

    Ultradent Products is recalling Transcend Singles Universal Body dental composite resin due to red particulates found during manufacturing. The recall affects approximately 2,450 units distributed in the US and several foreign countries.

    Product
    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 d
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-3067-2024·2024-09-18

    Dental Composite Resin Recall Due to Red Particulate Contamination

    Ultradent Products recalls Transcend Econo Kit dental composite due to red particulates in the material from a manufacturing issue. Affected lot C1464 was distributed to dental professionals in 34 U.S. states and internationally.

    Product
    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 composite material (Bis-GMA-based) to be used for direct and indir
    Category
    Medical Device
    Distribution
    35 states
  • ModerateFDA (Devices)·Z-3066-2024·2024-09-18

    Ultradent Recalls Vit-l-escence Composite Due to Red Particulates

    Ultradent is recalling Vit-l-escence Singles A3 composite restorative material because a manufacturing issue resulted in red particulates being present in the expressed composite.

    Product
    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% fi
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-1368-2022·2022-07-20

    Dental bonding primer may lack resin component affecting restoration

    Ultradent Peak Universal Bond self-etch dental primers may be missing resin, potentially compromising bond strength. Affected products were distributed nationwide and internationally.

    Product
    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 dental bonding procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0053-2021·2020-10-14

    Ultradent PermaFlo Flowable Composite Recalled for Manufacturing Cross-Contamination

    Ultradent Products, Inc. is recalling PermaFlo Flowable Composite due to a potential manufacturing issue causing cross-contamination and non-homogeneity.

    Product
    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 distribution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0690-2019·2019-01-09

    Ultradent Recalls Enamelast Fluoride Varnish Due to Off-Flavor Complaints

    Ultradent Products, Inc. is recalling specific lots of Enamelast 5% Sodium Fluoride Varnish because the product may have an unpleasant or off flavor.

    Product
    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 Enamelast Unit Dose 50pk Cool Mint: Enamelast 5% Sodium Fluori
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3214-2017·2017-10-04

    Ultradent Paper Points Recalled for Sterile Barrier Labeling Error

    Ultradent Products is recalling sterile Paper Points because the barcode label was placed underneath the sterile barrier, compromising the product's sterile status.

    Product
    Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3217-2017·2017-10-04

    Ultradent Paper Points Recalled Due to Sterile Barrier Labeling Error

    Ultradent Products, Inc. is recalling sterile Paper Points because the barcode label was placed underneath the sterile barrier and the product was re-wrapped.

    Product
    Ultradent Products, Inc. Paper Points, Size 45 PN #1558, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins..
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3218-2017·2017-10-04

    Ultradent Paper Points Recalled Due to Sterile Barrier Labeling Error

    Ultradent Products is recalling sterile Paper Points because the barcode label was placed underneath the sterile barrier, compromising the product's sterility.

    Product
    Ultradent Products, Inc. Paper Points, Size 50 PN #1559, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins..
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3215-2017·2017-10-04

    Ultradent Paper Points Recalled Due to Sterile Barrier Label Placement

    Ultradent Products is recalling sterile Paper Points because the barcode label was placed underneath the sterile barrier, potentially compromising sterility.

    Product
    Ultradent Products, Inc. Paper Points, Size 25 PN #1554, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3216-2017·2017-10-04

    Ultradent Paper Points Recalled Due to Sterile Barrier Labeling Error

    Ultradent Products, Inc. is recalling sterile Paper Points because the barcode label was placed underneath the sterile barrier and the product was re-wrapped.

    Product
    Ultradent Products, Inc. Paper Points, Size 30 PN #1555, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1034-2017·2017-01-25

    Ultradent NanoTips 30g Dental Tips Recalled for Loose Cannula

    Ultradent Products, Inc. is recalling NanoTips 30g dental tips because the stainless steel cannula may detach from the base, posing a risk during intra-oral procedures.

    Product
    NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection molded royal blue tips that contain stainless steel 30-gauge cannula to aid in the delivery of chemicals. The NanoTip base is made from a polypropylene copolymer. The stainless steel cannula is made from
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0704-2017·2016-12-14

    Ultradent Recalls UltraSeal XT Plus Clear Refill Due to Labeling Error

    Ultradent Products, Inc. is recalling 31 units of UltraSeal XT Plus Clear Refill, Lot BD79T, because the package was mislabeled with an incorrect part number.

    Product
    UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. Product Usage: The UltraSeal XT Plus is used for prophylactic sealing of pits and fissures. It may also be used for micro restorative or initial layer of composite restorations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0583-2016·2016-01-13

    Ultradent Recalls InterGuard Dental Refills Due to Manufacturing Defect

    Ultradent is recalling InterGuard 5.5mm Econo Refills because the floss tether hole was not completely punched through.

    Product
    InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 Product Usage: InterGuard is a preventive aid for operative dentistry. It is used to protect adjacent teeth from iatrogenic preparation damage. This includes cavity and tunnel pre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0481-2014·2013-12-18

    Ultradent Recalls Avex CX2 Ceramic Orthodontic Brackets Due to Design Control Issues

    Ultradent is recalling 217 units of Avex CX2 Ceramic Orthodontic Brackets because the design control process was not completed before distribution.

    Product
    Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1271-2013·2013-04-03

    Ultradent Recalls Opalescence Treswhite Supreme Peach Patient Kits

    Ultradent Products, Inc. is recalling 104 units of Opalescence Treswhite Supreme Peach Patient Kits due to incorrect shelf-life labeling.

    Product
    Opalescence Treswhite Supreme Peach Patient Kit
    Category
    Medical Device
    Distribution
    13 states
  • LowFDA (Devices)·Z-0876-2013·2013-03-06

    Ultradent Recalls Mislabelled Avex CX Orthodontic Brackets

    Ultradent Products, Inc. is recalling 124 units of Avex CX orthodontic brackets due to incorrect labeling. The affected products were distributed nationwide in the US.

    Product
    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. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0812-2013·2013-02-20

    Ultradent Chromaclone PVS Impression Material Recalled for Packaging Error

    Ultradent Products is recalling specific lots of Chromaclone PVS impression material due to incorrect packaging of regular and fast set cartridges.

    Product
    Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0811-2013·2013-02-20

    Ultradent Chromaclone PVS Impression Material Recalled for Packaging Error

    Ultradent Products is recalling specific lots of Chromaclone PVS impression material due to incorrect packaging of regular and fast set cartridges.

    Product
    Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1708-2012·2012-07-11

    Ultradent Recalls Cinnamon Xylishield Gum Due to Missing Soy Allergen Labeling

    Ultradent is recalling 36 lots of Cinnamon Xylishield gum because the packaging fails to list soy as an ingredient. The gum was distributed globally.

    Product
    Cinnamon Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack. Packaging is red, white, and black with black, red and white print writing. The product is advertised for use in fighting against tooth decay. Part number 8419.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1709-2012·2012-07-11

    Ultradent Recalls Cinnamon Xylishield Gum Due to Missing Soy Allergen Labeling

    Ultradent is recalling 36 lots of cinnamon Xylishield gum because the ingredients label failed to list soy, a major allergen.

    Product
    Xylishield Dental Care Kit containing 60 pieces of Cinnamon Xylishield gum. The product is packaged in blue and white packaging with black and white print writing. The product is advertised as a defense against cavities. Part number 8405.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1710-2012·2012-07-11

    Ultradent Recalls Xylishield Gum for Missing Soy Allergen Labeling

    Ultradent is recalling specific lots of Xylishield gum because the packaging failed to list soy as an ingredient. A separate lot of spearmint gum was also recalled due to accidental cinnamon flavoring.

    Product
    Spearmint Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack. Packaging is aqua, blue and white with black, aqua and white print writing. The product is advertised for use in fighting against tooth decay. Part number 8418.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1822-2012·2012-06-27

    Ultradent Recalls Peak SE Primer Kits Due to Mislabeled Syringes

    Ultradent is recalling specific Peak SE Primer Kits because a syringe was mislabeled as Peak LC Bond Resin, posing a risk to dental bonding procedures.

    Product
    Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with bl
    Category
    Medical Device
    Distribution
    0 states