Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 Recalled by Ultradent Products, Inc. Due to Mislabeling
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ultradent Products, Inc. directly.
Affected Products
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.
Quantity: 31
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ultradent Products, Inc.
Ultradent Products, Inc. has 23 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report