Helioseal F Sealant Refill 1 x 1 — Class II medical device recall Z-0213-2016
Terminated recall by Ivoclar A. G., reported 2015-11-11, distributed nationwide. A defect occurred in the production process of Helioseal F Sealant; the particles in the faulty component seem
| Recall number | Z-0213-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ivoclar A. G., Schaan, N/A, Liechtenstein |
| Recall initiated | 2015-10-07 |
| Classified | 2015-11-04 |
| Reported by FDA | 2015-11-11 |
| Terminated | 2016-06-14 |
| Distributed | Nationwide (US) |
| Quantity | 337 units |
| Lot numbers | U12511, U19925 |
| Model numbers | 1.25, 558518AN, 558519AN |
| Expiration dates | 2017-11-09 |
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 fissure sealant featuring fluoride release. Helioseal fissure sealants are suitable for the sealing of pits, fissures and foramina caeca.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0213-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.