Adhese 2 Dental Amalgam Recall, Ivoclar Vivadent AG

ANSM Drug & Device Safety Alerts

Filed April 3rd, 2026

Detected April 3rd, 2026

Summary

ANSM issued safety alert R2609516 regarding a batch recall of Adhese 2 dental amalgam by Ivoclar Vivadent AG. Healthcare facilities, dental centers, and dental surgeons using this product should verify their inventory for affected lots. The company has directly notified impacted users with return instructions.

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What changed

ANSM (French National Agency for Medicines and Health Products Safety) has recorded a batch withdrawal (recall) of Adhese 2 dental amalgam manufactured by Ivoclar Vivadent AG under safety action reference R2609516. The company initiated the recall and has issued direct notification to affected users with instructions.

Dental practices, health centers, and hospitals should immediately check their inventory for Adhese 2 dental amalgam from affected lots and follow the return procedures provided in the company letter. Users with questions should contact Ivoclar Vivadent AG directly. The recall is currently in progress and regulated entities should act promptly to prevent continued use of the affected product.

What to do next

Check inventory for Adhese 2 dental amalgam from the affected lot(s)
Follow return instructions provided by Ivoclar Vivadent AG
Contact Ivoclar Vivadent AG directly for questions regarding the recalled product

Source document (simplified)

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Rappel n° R2609516 destiné aux établissements de santé, centres de santé et chirurgiens dentistes L'ANSM a été informée de la mise en œuvre d’un retrait de lot effectué par la société Ivoclar Vivadent AG.

Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2609516. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Téléchargez le courrier de la société Ivoclar Vivadent AG (03/04/2026)