Heraeus Medical GmbH (Dental Division) recalls Heraeus

Recalling company

Heraeus Medical GmbH (Dental Division)

Product

Heraeus, PALAMIX duo. Material Number: 66057897.

Reason

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).

Classification

Class III – not likely to cause adverse health consequences

Recall date

Mar 25, 2026

Reported

May 6, 2026

Distribution

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, Mexico, Netherlands, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Rep. of Korea, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom, Uruguay, Utd.Arab Emir.;

Status

Ongoing

Quantity

1,125 units

Lot / codes

Material Number: 66057897; UDI-DI: 04260102133617; Batch: all batches with numbers below 520215;

Company location

Wehrheim

Recall type

Voluntary: Firm initiated

Recall number

Z-1998-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1998-2026 in the FDA Enforcement Report. Also see FDA recall press releases.