FDA recall, , Low risk
Heraeus PALAMIX Duo and Uno
The PALAMIX uno mixing rod may come loose during mixing in units older than ̈1.5 years.
Summary by Recall Canary from the FDA notice
What happened
Heraeus Medical GmbH (Dental Division) of Wehrheim, Germany, recalled Heraeus Palamix uno and Heraeus Palamix duo mixing units because, based on long-term stability testing, the mixing rod may, in rare cases, come loose from its lock during the mixing process in units older than 1.5 years (17 months). The recall began March 25, 2026, and was added to the FDA's Enforcement Report on April 29, 2026.
The products were distributed nationwide and worldwide, including in the United States and many other countries.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Heraeus, PALAMIX uno. Material Number: 66057893.
- UDI-DI
- 66057893
- 04260102133587
- Lot code
- 223060
Heraeus, PALAMIX duo. Material Number: 66057897.
- UDI-DI
- 66057897
- 04260102133617
- Lot code
- 520215
Recall details
- Company began the recall
- Sold in
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.;
- Company
- Heraeus Medical GmbH (Dental Division)Wehrheim, Germany
- Hazard
- Device defect
- Risk
Low risk
Using it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 98608
- Recall numbers
- Z-1997-2026 to Z-1998-2026
All recalls from Heraeus Medical GmbH (Dental Division)
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
