Ultradent Products, Inc.
Complete recall history across all FDA and CPSC categories — 23 total recalls
Recall Summary
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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