Severity
Low
Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501
Reported: February 28, 2018 Initiated: August 3, 2017 #Z-0665-2018 2,153 units units
Ivoclar Vivadent, Inc. issued this FDA Devices recall on February 28, 2018. Classified as Low severity (Class III). Approximately 2,153 units units are affected. The recall was issued because: Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consiste…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-0665-2018) was formally reported on February 28, 2018, with the manufacturer initiating the action on August 3, 2017. It is classified under Low severity (Class III), with a current status of Terminated. Ivoclar Vivadent, Inc. is listed as the recalling firm, operating out of Amherst, NY. Federal records indicate 2,153 units units are affected.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: US and Canada. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 8 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
2,153 units
Related Recalls
6
6 from same agency
Product Description
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.
Details
- Recalling Firm
- Ivoclar Vivadent, Inc.
- Units Affected
- 2,153 units
- Distribution
- US and Canada
- Location
- Amherst, NY
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0665-2018 |
| Date reported | February 28, 2018 |
| Date initiated | August 3, 2017 |
| Recalling firm | Ivoclar Vivadent, Inc. |
| Units affected | 2,153 units |
| Distribution | US and Canada |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501. Recalled by Ivoclar Vivadent, Inc.. Units affected: 2,153 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 28, 2018. Severity: Low. Recall number: Z-0665-2018.
Where was the recalled product distributed? ▼
Distribution: US and Canada.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0665-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).