PALAMIX recallZ-1998-2026 · Heraeus Medical GmbH (Dental Division) · initiated Mar 25, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Heraeus Medical GmbH (Dental Division) or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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).
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1998-2026
- Status
- Open, Classified
- Initiated by the company
- Mar 25, 2026
- Posted by the FDA
- Apr 29, 2026
- Recalling firm
- Heraeus Medical GmbH (Dental Division)
- Quantity
- 1,125 units
- Product code
- JDZ
- 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.;
Product description
Heraeus, PALAMIX duo. Material Number: 66057897.
Code information (models, lots, serial numbers)
Material Number: 66057897; UDI-DI: 04260102133617; Batch: all batches with numbers below 520215;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- PALAMIX® DUOHeraeus Medical GmbH · Mixer, Cement, For Clinical Use1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 98608).
- Z-1997-2026 · Open, ClassifiedHeraeus, PALAMIX uno. Material Number: 66057893.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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