Heraeus, PALAMIX uno. Material Number: 66057893.
Summary
The FDA issued a Class III for Heraeus, PALAMIX uno. Material Number: 66057893. by Heraeus Medical GmbH (Dental Division). 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 f.
Details
Source
Device Recall
External ID
Z-1997-2026
Action Date
2026-05-06
Status
Ongoing
Category
device
Product Description
Heraeus, PALAMIX uno. Material Number: 66057893.
Lot/Code Info: Material Number: 66057893; UDI-DI: 04260102133587; Batch: all batches with numbers below 223060;
Quantity Affected: 51,771 units
Reason for Recall
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).
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.;
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-25
Company
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 275 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Heraeus Medical GmbH (Dental Division) has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Heraeus Medical GmbH (Dental Division)) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Heraeus Medical GmbH (Dental Division) have FDA actions?
Heraeus Medical GmbH (Dental Division) has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1997-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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