CLASS III Device recall · Reported 28 Feb 2018 · FDA Enforcement Report

Heliomolar Refill . 140/A2, Product recalled by Ivoclar Vivadent

Ivoclar Vivadent is recalling Heliomolar Refill . 140/A2, Product. The recall was initiated on 3 Aug 2017 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesBatch: 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

Quantity recalled3,255 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0666-2018
FDA event ID: 79064
Recalling firm: Ivoclar Vivadent, Amherst, NY
Classification: Class III
Status: Terminated
Recall initiated: 3 Aug 2017
FDA classified: 21 Feb 2018
Reported: 28 Feb 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

3 Aug 2017	Recall initiated by company
21 Feb 2018	Classified by FDA	+202 days
28 Feb 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502

Where it was distributed

US and Canada

Questions about this recall

Is Heliomolar Refill . 140/A2, Product recalled?

Yes. Ivoclar Vivadent recalled Heliomolar Refill . 140/A2, Product on 3 Aug 2017. The recall is Class III and its status is Terminated. Recall number Z-0666-2018.

Why was it 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 lots are affected?

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

Where was it sold?

US and Canada

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Ivoclar Vivadent

All 34

Reported	Class	Recall	Company	Reason	Where
14 Feb 2024Device	CLASS II	Article No. NA6050411, Valiant PhD No. 1 Econo recalled	Ivoclar Vivadent	Device Malfunction	Nationwide
28 Feb 2018Device	CLASS III	Heliomolar Refill . 210/A3, Product recalled by Ivoclar Vivadent	Ivoclar Vivadent	Other	NY
28 Feb 2018Device	CLASS III	Heliomolar Refill . 110T, Product recalled by Ivoclar Vivadent	Ivoclar Vivadent	Other	NY
28 Feb 2018Device	CLASS III	Heliomolar Refill . 110/A1, Product recalled by Ivoclar Vivadent	Ivoclar Vivadent	Other	NY
14 Dec 2016Device	CLASS II	Virtual XD Refill Light Body Fast Set Wash Material, ml recalled	Ivoclar Vivadent	Other	Nationwide

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