Heraeus Medical GmbH (Dental Division) recalls Heraeus, PALAMIX uno. Material Number: 66057893.

Recall date

March 25, 2026

Source

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

Recall number

Z-1997-2026

FDA classification

Class III

Brand / firm

Heraeus Medical GmbH (Dental Division)

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Aland Islands, Algeria, Australia, Austria, Belgium, Brazil , Chile, China, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Kosovo, Lithuania, Luxembourg, Malaysia, Malta,…

Why it was recalled

Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Heraeus, PALAMIX uno. Material Number: 66057893.