Ivoclar Recalls Helioseal F Dental Sealant Due to Production Defect
Ivoclar A. G. is recalling specific lots of Helioseal F dental sealant because a production defect caused particles to be larger than defined, resulting in difficulties during extrusion.
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, but the source text describes a production defect affecting extrusion without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ivoclar A. G. is recalling Helioseal F Sealant Refill 1 x 1.25 g (REF 558519AN) and Helioseal F Assortment (kit) 5 x 1.25 g (REF 558518AN). The affected products are identified by Lot U12511 and Kit Lot U19925 (for the Assortment only), with an expiration date of 11.09.2017. A total of 337 units were distributed domestically.
The recall was initiated due to a defect in the production process where particles in the faulty component were larger than the size defined in the formula. This defect results in difficulties during the extrusion of the material. The agency has classified this as a Class II recall.
The products were distributed nationwide, including in New Jersey, Pennsylvania, South Carolina, Florida, Indiana, Iowa, Wisconsin, Illinois, Missouri, Texas, California, and Washington. Consumers and dental professionals should stop using the affected lots and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- 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…
- Manufacturer
- Ivoclar A. G.
- Category
- Medical Device — Dental Sealant
- Affected units
- 337
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 (3)
- Lot U12511
- Kit Lot U19925 (Helioseal F Assortment only)
- exp. 11.09.2017
Distribution
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