Heliomolar Refill 20x0 — Class III medical device recall Z-0665-2018
Terminated recall by Ivoclar Vivadent, Inc., reported 2018-02-28. Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual
| Recall number | Z-0665-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ivoclar Vivadent, Inc., Amherst, NY, United States |
| Recall initiated | 2017-08-03 |
| Classified | 2018-02-21 |
| Reported by FDA | 2018-02-28 |
| Terminated | 2018-08-28 |
| Countries outside the US | CA |
| Quantity | 2,153 units |
| Lot numbers | V35109, V40817, V48597, V48938, W12251 |
| Model numbers | 110/A1, 20X0.25G, 541501 |
| Expiration dates | 2020-01-10 |
Product
Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501
Reason for 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0665-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.