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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72290

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 07, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ivoclar A. G.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0213-2016
Recall number
Z-0213-2016
Initiated
October 07, 2015
Classification
Class II
Status
Terminated
Recalling firm
Ivoclar A. G.
Quantity
Domestic: 337 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
defect occurred in the production

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot U12511, Kit Lot U19925 (Helioseal F Assortment only), exp. 11.09.2017

Distribution pattern

Nationwide Distribution including NJ, PA, SC, FL, IN, IA, WI, IL, MO, TX, CA and WA.