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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93877

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 25, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Voco GmbH

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

2 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 2

IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement

Z-1142-2024
Recall number
Z-1142-2024
Initiated
January 25, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Voco GmbH
Quantity
1530 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
error in the manufacturing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.

Code information

a) 2540, UDI/DI +E22125401, Lot Numbers: 2338699, 2347154; b)2543, UDI/DI +E22125431, Lot Numbers: 2344046; c) 2544, UDI/DI +E22125441, Lot Numbers: 2342759, 2439537; d) 2545, UDI/DI +E22125451, Lot Numbers: 2348503; e) 2546, UDI/DI +E22125461, Lot Numbers: 2344045, 2349452; f) 2547, UDI/DI +E22125471, Lot Numbers: 2349453; g) 2549, UDI/DI +E22125491, Lot Numbers: 2342760, 2344016, 2344047, 2351233

Distribution pattern

Worldwide distribution: US distribution to states of: IA, NY, PA, WA; and OUS (foreign) to countries of: Belgium, Bulgaria, Denmark, Germany, France, Greece, Great Britain, India, Italy, Canada, Quatar, Lithuania, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Sweden, Switzerland, Slovakia, Spain, Czech Republic, Australia, Saudi Arabia, & Ireland.

device · product 2 of 2

Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement

Z-1143-2024
Recall number
Z-1143-2024
Initiated
January 25, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Voco GmbH
Quantity
1021 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
error in the manufacturing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.

Code information

a) 2115, UDI/DI +E22121151, Lot Numbers: 2346779, 2401515; b) 2117, UDI/DI +E22121171, Lot Numbers: 2347832; c) 2118, UDI/DI +E22121181, Lot Numbers: 2349536; d) 2119, UDI/DI +E22121191, Lot Numbers: 2348501; e) 2120, UDI/DI +E22121201, Lot Numbers: 2350638; f) 2122, UDI/DI +E22121221, Lot Numbers: 2349527

Distribution pattern

Worldwide distribution: US distribution to states of: IA, NY, PA, WA; and OUS (foreign) to countries of: Belgium, Bulgaria, Denmark, Germany, France, Greece, Great Britain, India, Italy, Canada, Quatar, Lithuania, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Sweden, Switzerland, Slovakia, Spain, Czech Republic, Australia, Saudi Arabia, & Ireland.