Ivoclar Vivadent Recalls Heliomolar Refill Due to Consistency Issues
Ivoclar Vivadent is recalling Heliomolar Refill units because the material was reported to be too soft and sticky, causing handling difficulties.
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 recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a cosmetic/functional defect (consistency) rather than a safety hazard.
Plain-English summary
Ivoclar Vivadent, Inc. is recalling 3,255 units of Heliomolar Refill 20x0.25g 140/A2 (Product code 541502AN, Catalog number 541502). The affected units were distributed in the US and Canada. Specific batches involved include V37176, V40818, V45145, V51367, W00520, W01514, W07036, and W13323, 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 deviation caused unexpected handling for the user during the packing and contouring process.
The U.S. Food and Drug Administration has classified this recall as Class III. Consumers and healthcare professionals should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- Product
- Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502
- Manufacturer
- Ivoclar Vivadent, Inc.
- Category
- Medical Device — Dental Material
- Hazard
- Affected units
- 3,255
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 (16)
- 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
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
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