Heraeus, PALAMIX duo. Material Number: 66057897.
FDA Recall Z-1998-2026 · Posted 2026-04-29
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Recalling FirmHeraeus Medical GmbH (Dental Division)
Recall StatusOpen, Classified
Product CodeJDZ
Date Initiated2026-03-25
Product Quantity1,125 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).
Firm Action
On 03/25/2026 Field Safety Notice letters were sent to customers.
Actions to be taken:
1. Read this Field Safety Notice and ensure that all relevant hospital departments are informed about its content.
2. Please complete the attached customer reply form and send it to [email protected] within five (5) calendar days. This form must be returned even if you no longer use the device.
3. Keep a copy of the attached customer reply form with your records in the event of a compliance audit of your facility.
Root Cause
Under Investigation by firm
Distribution Pattern
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.;
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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