🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: February 12, 2016 Ivoclar Vivadent Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    REF/Product Code/Art. No. 558521AN, Lot U29336 (exp. 10/5/2020); REF/Product Code/Art. No. 558520AN, Lots U33966, U35661, U50469 (exp. 10/5/2020)
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Ivoclar Vivadent, Inc.
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

REF/Product Code/Art. No. 558521AN, Lot U29336 (exp. 10/5/2020); REF/Product Code/Art. No. 558520AN, Lots U33966, U35661, U50469 (exp. 10/5/2020)

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1026-2016

Related Recalls

Article No. NA6050411, Valiant PhD No. 1 Econo

Ivoclar Vivadent

Class I - Dangerous

Affected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. strength, compression, working time, etc.) will be adversely affected.

Dec 21, 2023 Other Medical Devices Nationwide View Details →