Ivoclar Vivadent Heliomolar Refill 20x0.25g 110/A1: Sticky Material Risk
Ivoclar Vivadent recalls Heliomolar Refill 20x0.25g 110/A1 product due to overly sticky material causing handling issues during dental work. Affected units have specific batch numbers and expiration dates.
Lower-risk recall
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.
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What happened, in plain English
Ivoclar Vivadent is recalling Heliomolar Refill 20x0.25g 110/A1 dental material because it's too sticky and soft, making it difficult to handle during dental procedures. This could lead to unexpected handling issues for users. Read more at govinfonow.com/recall/73254-ivoclar-vivadent-heliomolar-refill-20x0-25g-110-a1-sticky-material.
Source Summary by GovInfoNow · govinfonow.com/recall/73254-ivoclar-vivadent-heliomolar-refill-20x0-25g-110-a1-sticky-material · Updated September 19, 2026 · FDA enforcement record: FDA #Z-0665-2018
Cite this page
“Ivoclar Vivadent Heliomolar Refill 20x0.25g 110/A1: Sticky Material Risk.” GovInfoNow, updated September 19, 2026. https://govinfonow.com/recall/73254-ivoclar-vivadent-heliomolar-refill-20x0-25g-110-a1-sticky-material. Based on FDA recall #Z-0665-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0665-2018%22&limit=1).
Why it’s dangerous
The material is reported to be too sticky and soft compared to standard consistency, which can cause unexpected handling difficulties when packing and contouring dental restorations.
Who’s affected
Dental professionals using the Heliomolar Refill 20x0.25g 110/A1 product are likely affected. Those with the specific batch numbers and expiration dates listed in the recall are most at risk.
How to tell if you have this one
Check for the product code 541501AN and catalog number 541501. Affected units include specific batches with expiration dates: V35109 (01.10.2020), V40817 (13.11.2020), V48597 (30.12.2020), V48938 (31.12.2020), and W12251 (31.03.2021).
- Brand
Ivoclar Vivadent- Category
Medical device
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
US and Canada
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0665-2018 | 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 | 2,153 units |
| Z-0666-2018 | 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 | 3,255 units |
| Z-0667-2018 | 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 | 1,244 units |
| Z-0668-2018 | Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559; Batch: W12503, Exp. date: 01.04.2021 | 2 units |
What to do — step by step
Check Product Details
Verify your product has the code 541501AN and catalog number 541501 with the listed batch numbers and expiration dates.
How this recall unfolded
Recall timeline
FDA terminated this recall 13 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The recall states the material is too sticky and soft, causing handling issues, but no specific safety risks are mentioned. The product may still be usable with caution.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0665-2018 (August 3, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0665-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.