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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices

Voco GmbH: IonoStar Plus and Ionolux Dental Cements Recalled for Incomplete Curing Risk

Agency Publication Date: February 16, 2024
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Summary

Voco GmbH has recalled approximately 2,551 units of IonoStar Plus and Ionolux dental cement capsules because some were manufactured with an incorrect plunger. This defective plunger lacks the necessary reactive component required for the cement to harden correctly, causing it to remain soft or experience significant curing delays. The recall affects several catalog and lot numbers of these dental materials used in professional settings.

Risk

The incorrect plunger prevents the dental cement from curing, which makes the product unusable according to instructions. This can result in failed dental restorations or procedures that lack necessary structural integrity.

What You Should Do

  1. Identify if you have affected IonoStar Plus capsules by checking for catalog (REF) numbers 2540, 2543, 2544, 2545, 2546, 2547, or 2549.
  2. Identify if you have affected Ionolux capsules by checking for catalog (REF) numbers 2115, 2117, 2118, 2119, 2120, or 2122.
  3. Check your stock for specific affected lot numbers: 2338699, 2347154, 2344046, 2342759, 2439537, 2348503, 2344045, 2349452, 2349453, 2342760, 2344016, 2344047, 2351233, 2346779, 2401515, 2347832, 2349536, 2348501, 2350638, or 2349527.
  4. Immediately stop using capsules from any of the affected lots identified above.
  5. Contact your healthcare provider or Voco GmbH directly for instructions on returning the defective product and receiving further guidance.
  6. Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.

Your Remedy Options

๐Ÿ“‹Other Action

The manufacturer initiated the recall due to a production error affecting the curing reactive component.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: IonoStar Plus (REF 2540)
Model / REF:
2540
UDI/DI +E22125401
Lot Numbers:
2338699
2347154
Product: IonoStar Plus (REF 2543)
Model / REF:
2543
UDI/DI +E22125431
Lot Numbers:
2344046
Product: IonoStar Plus (REF 2544)
Model / REF:
2544
UDI/DI +E22125441
Lot Numbers:
2342759
2439537
Product: IonoStar Plus (REF 2545)
Model / REF:
2545
UDI/DI +E22125451
Lot Numbers:
2348503
Product: IonoStar Plus (REF 2546)
Model / REF:
2546
UDI/DI +E22125461
Lot Numbers:
2344045
2349452
Product: IonoStar Plus (REF 2547)
Model / REF:
2547
UDI/DI +E22125471
Lot Numbers:
2349453
Product: IonoStar Plus (REF 2549)
Model / REF:
2549
UDI/DI +E22125491
Lot Numbers:
2342760
2344016
2344047
2351233
Product: Ionolux (REF 2115)
Model / REF:
2115
UDI/DI +E22121151
Lot Numbers:
2346779
2401515
Product: Ionolux (REF 2117)
Model / REF:
2117
UDI/DI +E22121171
Lot Numbers:
2347832
Product: Ionolux (REF 2118)
Model / REF:
2118
UDI/DI +E22121181
Lot Numbers:
2349536
Product: Ionolux (REF 2119)
Model / REF:
2119
UDI/DI +E22121191
Lot Numbers:
2348501
Product: Ionolux (REF 2120)
Model / REF:
2120
UDI/DI +E22121201
Lot Numbers:
2350638
Product: Ionolux (REF 2122)
Model / REF:
2122
UDI/DI +E22121221
Lot Numbers:
2349527

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93877
Status: Active
Manufacturer: Voco GmbH
Sold By: Dental distributors; Medical supply retailers
Manufactured In: Germany
Units Affected: 2 products (1530 units; 1021 units)
Distributed To: Iowa, New York, Pennsylvania, Washington
Agency Last Updated: February 21, 2024

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.