Heraeus Medical Gmbh (dental Division) Philipp-reis-str. 8 Wehrheim Germany: Mixer, Cement, For Clinical Use
- Recalling firm
- Heraeus Medical GmbH (Dental Division) Philipp-Reis-Str. 8 Wehrheim Germany
- Product
- Heraeus, PALAMIX uno. Material Number: 66057893.
- 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).
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-25
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/8cd91a46-1de3-4775-b653-8f0683ca61b3