The Recall Desk
LowFDA (Devices)·Z-0667-2018·Announced 2018-02-28

Ivoclar Vivadent Recalls Heliomolar Refill Due to Inconsistent Material Handling

Ivoclar Vivadent is recalling Heliomolar Refill units because complaints reported the material was too soft and sticky, causing unexpected handling difficulties.

What this means for you

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

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

Plain-English summary

Ivoclar Vivadent, Inc. is recalling 1,244 units of Heliomolar Refill 20x0.25g 210/A3 (Product code 541503AN, Catalog number 541503). The affected products were distributed in the US and Canada. Specific batches involved include V37905, V45006, V49583, W04412, and W13322, with expiration dates ranging from October 2020 to April 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 inconsistency caused unexpected handling for the user during packing and contouring. The agency has classified this recall as Class III.

Users of these products should stop using the affected units and contact the manufacturer for further instructions. No specific illnesses or injuries were reported in the source text.

The recalled product

Product
Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503
Manufacturer
Ivoclar Vivadent, Inc.
Category
Medical Device — Dental Materials
Hazard
Affected units
1,244

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 (10)

  • 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

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 →

Related recalls

Same manufacturer · Ivoclar Vivadent, Inc.

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Same hazard · handling defect

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