FDA Device recall Z-0665-2018
Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501
- FDA Device
- Class III
- terminated
- Published 2018-02-28
On 2018-02-28 the FDA classified a Class III recall of Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501 by Ivoclar Vivadent, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0665-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-08-03 |
| Published | 2018-02-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ivoclar Vivadent |
| Distribution | n/a |
Product
Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501
Reason
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.
Identifiers
| code_info | Batch: V35109 Exp. date: 01.10.2020; Batch: V40817 Exp. date: 13.11.2020; Batch: V48597 Exp. date: 30.12.2020; Batch: V…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0665-2018%22
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