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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error where the product itself was correctly identified, fitting the criteria for moderate severity.
Plain-English summary
Ultradent Products, Inc. is recalling 31 units of UltraSeal XT Plus Clear Refill, Part Number 565, Lot BD79T. The product is used for prophylactic sealing of pits and fissures and for micro restorative or initial layers of composite restorations.
The recall was initiated due to a labeling error. The package was mislabeled as PQ1, Part Number 641, while the barcode, instructions for use, and the product itself were correctly labeled for UltraSeal XT Plus Clear Refill, Part Number 565, Lot BD79T.
The affected units were distributed worldwide and nationwide in the US. Consumers and healthcare providers should stop using the affected product and contact Ultradent Products, Inc. for further instructions.
The recalled product
- 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.
- Manufacturer
- Ultradent Products, Inc.
- Hazard
- Affected units
- 31
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot BD79T
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Ultradent Products, Inc.
See all →- HighJiffy composite polisher cups may crumble and break apart easily
FDA (Devices) · 2026-04-08
- HighDental Composite Resin Recall Due to Red Particulate Contamination
FDA (Devices) · 2024-09-18
- ModerateUltradent Recalls Vit-l-escence Composite Due to Red Particulates
FDA (Devices) · 2024-09-18
- HighFDA Recalls Transcend Dental Composite Material Due to Manufacturing Defect
FDA (Devices) · 2024-09-18
- HighDental bonding primer may lack resin component affecting restoration
FDA (Devices) · 2022-07-20
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
Similar recalls
- ModerateUltradent Recalls Peak SE Primer Kits Due to Mislabeled Syringes
FDA (Devices) · 2012-06-27
- LowUltradent Recalls InterGuard Dental Refills Due to Manufacturing Defect
FDA (Devices) · 2016-01-13
- ModerateUltradent Paper Points Recalled Due to Sterile Barrier Labeling Error
FDA (Devices) · 2017-10-04
- ModerateUltradent Paper Points Recalled for Sterile Barrier Labeling Error
FDA (Devices) · 2017-10-04
- LowUltradent Chromaclone PVS Impression Material Recalled for Packaging Error
FDA (Devices) · 2013-02-20
- LowConvaTec Flexi-Seal Signal Plus Recalled for Packaging Labeling Error
FDA (Devices) · 2013-08-28