FDA Medical Device Recalls (openFDA)
Heraeus Medical GmbH (Dental Division): Heraeus, PALAMIX duo. Material Number: 66057897.
- Recall number
- Z-1998-2026
- Recalling firm
- Heraeus Medical GmbH (Dental Division)
- Product
- Heraeus, PALAMIX duo. Material Number: 66057897.
- Status
- Open, Classified
- Initiated
- 2026-03-25
- Posted
- 2026-04-29
- Terminated
- not on file
- 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).
- Root cause
- Under Investigation by 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 hm.fsca.medical@heraeus.com 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.
- Quantity
- 1,125 units
- 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.;
- Lot, serial or model codes
- Material Number: 66057897; UDI-DI: 04260102133617; Batch: all batches with numbers below 520215;
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JDZ
- Firm FEI
- 3006406161
- Firm city
- Wehrheim
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28