The Recall Desk
Agency classClass IIIOur severity:LowFDA (Devices)·Z-0665-2018·Announced 2018-02-28

Ivoclar Vivadent Recalls Heliomolar Refill Due to Soft and Sticky Consistency

Ivoclar Vivadent is recalling Heliomolar Refill 20x0.25g 110/A1 because complaints reported the material was too soft and sticky, causing unexpected handling during use.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The agency classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a handling defect (consistency) rather than a direct safety hazard like infection or injury.

Plain-English summary

Ivoclar Vivadent, Inc. is recalling Heliomolar Refill 20x0.25g 110/A1 (Product code 541501AN, Catalog number 541501). The recall involves 2,153 units distributed in the US and Canada. Affected batches include V35109, V40817, V48597, V48938, and W12251, with expiration dates ranging from October 2020 to March 2021.

The recall was initiated after complaints were filed claiming the material consistency was too soft and too sticky compared to its usual consistency. This deviation caused unexpected handling for the user during packing and contouring. The agency has classified this as a Class III recall.

Consumers and healthcare professionals should stop using the affected product and contact Ivoclar Vivadent, Inc. for further instructions or a return.

The recalled product

Product
Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501
Manufacturer
Ivoclar Vivadent, Inc.
Category
Medical Device — Dental Material
Hazard
Affected units
2,153

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • 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

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 4 recalled by Ivoclar Vivadent, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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