CLASS II ONGOING Device recall · Reported 28 Feb 2024 · FDA Enforcement Report
Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) recalled by Voco
Voco is recalling Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e), distributed in Iowa, New York, Pennsylvania, Washington. The recall was initiated on 25 Jan 2024 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-1143-2024
- FDA event ID
- 93877
- Recalling firm
- Voco, Cuxhaven, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Jan 2024
- FDA classified
- 16 Feb 2024
- Reported
- 28 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Dental Devices
Timeline
| 25 Jan 2024 | Recall initiated by company | |
| 16 Feb 2024 | Classified by FDA | +22 days |
| 28 Feb 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement
Where it was distributed
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.
Questions about this recall
Is Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) recalled?
Yes. Voco recalled Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) on 25 Jan 2024. The recall is Class II and its status is Ongoing. Recall number Z-1143-2024.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
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.
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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