Reported Feb 28, 2018 · Terminated
Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501
Ivoclar Vivadent, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ivoclar Vivadent, Inc. · 175 Pineview Dr · Amherst, NY · 14228-2231
Is this the product you have?
Heliomolar Refill 20x0.25g 110/A1Product code 541501ANCatalog number 541501
- Lot codes and dates
- BatchV35109 Exp
- date01.10.2020
- BatchV40817 Exp
- date13.11.2020
- BatchV48597 Exp
- date30.12.2020
- BatchV48938 Exp
- date31.12.2020
- BatchW12251 Exp
- date31.03.2021
- Amount recalled
- 2,153 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Ivoclar Vivadent, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.