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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Device

Ivoclar Vivadent, Inc.: Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.

Agency Publication Date: February 21, 2018
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Affected Products

Product: Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501

Batch: V35109 Exp. date: 01.10.2020; Batch: V40817 Exp. date: 13.11.2020; Batch: V48597 Exp. date: 30.12.2020; Batch: V48938 Exp. date: 31.12.2020 Batch: W12251 Exp. date: 31.03.2021

Lot Numbers:
V35109
V40817
V48597
V48938
W12251
Product: Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502

Batch: V37176, Exp. date: 15.10.2020; Batch: V40818, Exp. date: 13.11.2020; Batch: V45145, Exp. date: 05.12.2020; Batch: V51367, Exp. date: 22.01.2021; Batch: W00520, Exp. date: 29.01.2021; Batch: W01514, Exp. date: 04.02.2021; Batch: W07036, Exp. date: 05.03.2021; Batch: W13323, Exp. date: 07.04.2021

Lot Numbers:
V37176
V40818
V45145
V51367
W00520
W01514
W07036
W13323
Product: Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503

Batch: V37905, Exp. date: 21.10.2020; Batch: V45006, Exp. date: 04.12.2020; Batch: V49583, Exp. date: 12.01.2021; Batch: W04412, Exp. date: 20.02.2021; Batch: W13322, Exp. date: 07.04.2021

Lot Numbers:
V37905
V45006
V49583
W04412
W13322
Product: Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559

Batch: W12503, Exp. date: 01.04.2021

Lot Numbers:
W12503

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79064
Status: Resolved
Manufacturer: Ivoclar Vivadent, Inc.
Manufactured In: United States
Units Affected: 4 products (2,153 units; 3,255 units; 1,244 units; 2 units)

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.