Helioseal Clear Refill 1 x 1 — Class II medical device recall Z-1026-2016
Terminated recall by Ivoclar Vivadent, Inc., reported 2016-03-09, distributed nationwide. Complaints were received claiming the material failed to polymerize under the curing light. After investigatio
| Recall number | Z-1026-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ivoclar Vivadent, Inc., Buffalo, NY, United States |
| Recall initiated | 2016-02-12 |
| Classified | 2016-02-29 |
| Reported by FDA | 2016-03-09 |
| Terminated | 2017-05-08 |
| Distributed | Nationwide (US) |
| Quantity | 406 units |
| Lot numbers | U29336, U33966, U35661, U50469 |
| Model numbers | 1.25 |
| Expiration dates | 2020-10-05 |
Product
Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ---- COMMON/USUAL NAME: Pit & Fissure Sealant
Reason for recall
Complaints were received claiming the material failed to polymerize under the curing light. After investigation, it was determined that a wrong photo-initiator was used in the production batch U30755 of Helioseal Clear. This failure can lead to incomplete curing of the sealant, if mono-wave LED curing lights are used.
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-1026-2016. 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.