Straumann USA LLC recalls Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;

Recall date

October 17, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0582-2026

FDA classification

Class II

Brand / firm

Straumann USA LLC

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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