Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Helioseal F Sealant Refill 1 x 1.25 g Recalled by Ivoclar A. G. Due to A defect occurred in the production process of...
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 Ivoclar A. G. directly.
Affected Products
Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed foil bag. Helioseal F is a light-curing, white-shaded fissure sealant featuring fluoride release. Helioseal fissure sealants are suitable for the sealing of pits, fissures and foramina caeca.
Quantity: Domestic: 337 units
Why Was This Recalled?
A defect occurred in the production process of Helioseal F Sealant; the particles in the faulty component seem to be larger than the size defined in the formula. This results in difficulties during extrusion of the material.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ivoclar A. G.
Ivoclar A. G. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report