Ultradent Products, Inc.

Complete recall history across all FDA and CPSC categories — 23 total recalls

Ultradent Products, Inc. appears in recall records across 2 categories. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Food Recalls (4)

FDA food safety enforcement actions by Ultradent Products, Inc.

Date Product Reason Class
Mar 8, 2013 Opalescence Treswhite Supreme Peach Patient Kit Product was packaged into kits labeled as having a shelf life of 2103-05. Th... Class III
Jun 18, 2012 Xylishield Dental Care Kit containing 60 pieces of Cinnamon Xylishield gum. ... Ultradent is recalling 36 lots of cinnamon flavored Xylishield gum sold in ca... Class II
Jun 18, 2012 Spearmint Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jord... Ultradent is recalling 36 lots of cinnamon flavored Xylishield gum sold in ca... Class II
Jun 18, 2012 Cinnamon Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jorda... Ultradent is recalling 36 lots of cinnamon flavored Xylishield gum sold in ca... Class II

Device Recalls (19)

FDA medical device enforcement actions by Ultradent Products, Inc.

Date Product Reason Class
Aug 2, 2024 Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Cata... Due to a manufacturing issue, red particulates present in the expressed compo... Class II
Aug 2, 2024 Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Mode... Due to a manufacturing issue, red particulates present in the expressed compo... Class II
Aug 2, 2024 Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Re... Due to a manufacturing issue, red particulates present in the expressed compo... Class II
Jun 1, 2022 Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Sel... SE primer may be missing some or all of the resin portion of the chemistry. T... Class II
Aug 31, 2020 PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light ... Due to a potential manufacturing issue (cross contamination), composite is no... Class II
Jul 12, 2018 Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk... Dental varnish has the possibility of having an unpleasant and off flavor. Class II
Aug 4, 2017 Ultradent Products, Inc. Paper Points, Size 30 PN #1555, 200 per container, ... The barcode label was placed underneath the sterile barrier and the product w... Class II
Aug 4, 2017 Ultradent Products, Inc. Paper Points, Size 45 PN #1558, 200 per container, ... The barcode label was placed underneath the sterile barrier and the product w... Class II
Aug 4, 2017 Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 200 per container, ... The barcode label was placed underneath the sterile barrier and the product w... Class II
Aug 4, 2017 Ultradent Products, Inc. Paper Points, Size 25 PN #1554, 200 per container, ... The barcode label was placed underneath the sterile barrier and the product w... Class II
Aug 4, 2017 Ultradent Products, Inc. Paper Points, Size 50 PN #1559, 200 per container, ... The barcode label was placed underneath the sterile barrier and the product w... Class II
Dec 14, 2016 NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection m... Ultradent Products, Inc. announces a voluntary field action for the NanoTips ... Class II
Nov 17, 2016 UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT ... There was a labeling error with product, UltraSeal XT Plus Clear Refill, Part... Class II
Dec 22, 2015 InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5... Ultradent is recalling InterGuard 5.5mm Econo Refill, lot#s BC2GN and BC4L7 b... Class II
Nov 19, 2013 Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex... Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Bra... Class III
Feb 8, 2013 Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Ave... Orthodontic brackets distributed was incorrectly labeled. Class III
Feb 4, 2013 Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, ... Incorrect packaging of regular set and fast set cartridges. Class III
Feb 4, 2013 Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavo... Incorrect packaging of regular set and fast set cartridges. Class III
May 24, 2012 Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, ... Ultradent is recalling lot B6Z4K of Peak SE Primer as a result of a field com... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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