Class II

Medical Device Recall: Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;

Straumann USA LLC · October 17, 2025

Reason for Recall

The possibility for this product that is intended for demonstration purposes only to be placed in patients.

Distribution

US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA.

States Affected

NATIONWIDE

Quantity Affected

61 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0582-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Straumann USA LLC Medical Device Recall: Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10; | SafeCheck