Heraeus recall (Heraeus Medical GmbH (Dental Division))
Medical deviceClass IIIOngoing
Summary: Heraeus Medical GmbH (Dental Division) is recalling 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).
What is being recalled
Heraeus, PALAMIX duo. Material Number: 66057897.
Why
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).
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
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 named: Puerto Rico)
How to tell if yours is affected
Material Number: 66057897; UDI-DI: 04260102133617; Batch: all batches with numbers below 520215;
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1998-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | March 25, 2026 |
| Reported | May 6, 2026 |
| Company | Heraeus Medical GmbH (Dental Division) |
| Company location | Wehrheim, Germany |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 1,125 units |
More recalls from Heraeus Medical GmbH (Dental Division) · all medical device recalls · recalls from March 2026