FDA Medical devices recall ·
Heraeus, PALAMIX duo recall
- Recall number
- Z-1998-2026
- Date
- (initiated March 25, 2026)
- Company / brand
- Heraeus Medical GmbH (Dental Division)
Philipp-Reis-Str. 8, Wehrheim, Germany - Category
- Medical devices › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 1,125 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Heraeus, PALAMIX duo. Material Number: 66057897.
Why was it 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).
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Material Number: 66057897; UDI-DI: 04260102133617; Batch: all batches with numbers below 520215;
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.;
States: Puerto Rico
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (medical devices), recall Z-1998-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.