CLASS II Device recall · Reported 11 Nov 2015 · FDA Enforcement Report
Helioseal F Sealant Refill g kits recalled by Ivoclar A. G
Ivoclar A. G is recalling Helioseal F Sealant Refill g kits, distributed nationwide in the US. The recall was initiated on 7 Oct 2015 and the FDA has classified it as Class II.
Check your package
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-0213-2016
- FDA event ID
- 72290
- Recalling firm
- Ivoclar A. G, Schaan, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Oct 2015
- FDA classified
- 4 Nov 2015
- Reported
- 11 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Particulate Matter
- Device type
- Syringes & Needles
Timeline
| 7 Oct 2015 | Recall initiated by company | |
| 4 Nov 2015 | Classified by FDA | +28 days |
| 11 Nov 2015 | 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
A defect occurred in the production process of Helioseal F Sealant; the particles in the faulty component seem to be larger than the size defined in the formula. This results in difficulties during extrusion of the material.
Product as listed by the FDA
Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed foil bag. Helioseal F is a light-curing, white-shaded fissure sealant featuring fluoride release. Helioseal fissure sealants are suitable for the sealing of pits, fissures and foramina caeca.
Where it was distributed
Nationwide Distribution including NJ, PA, SC, FL, IN, IA, WI, IL, MO, TX, CA and WA.
Nationwide CaliforniaFloridaIowaIllinoisIndianaMissouriNew JerseyPennsylvaniaSouth CarolinaTexasWashingtonWisconsin
Questions about this recall
Is Helioseal F Sealant Refill g kits recalled?
Yes. Ivoclar A. G recalled Helioseal F Sealant Refill g kits on 7 Oct 2015. The recall is Class II and its status is Terminated. Recall number Z-0213-2016.
Why was it recalled?
A defect occurred in the production process of Helioseal F Sealant; the particles in the faulty component seem to be larger than the size defined in the formula. This results in difficulties during extrusion of the material.
Which lots are affected?
Lot U12511, Kit Lot U19925 (Helioseal F Assortment only), exp. 11.09.2017
Where was it sold?
Nationwide Distribution including NJ, PA, SC, FL, IN, IA, WI, IL, MO, TX, CA and WA.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
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