Reported Mar 9, 2016 · Terminated
Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g,…
Ivoclar Vivadent, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ivoclar Vivadent, Inc. · 175 Pineview Dr · Buffalo, NY · 14228-2231
Is this the product you have?
- 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 NAMEPit & Fissure Sealant
- Lot codes and dates
REF/Product Code/Art. No. 558521ANLot U29336 (exp. 10/5/2020)REF/Product Code/Art. No. 558520ANLots U33966U35661U50469 (exp. 10/5/2020)
- Amount recalled
- Domestic: 406 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Ivoclar Vivadent, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.