Recall Z-1997-2026— Heraeus Medical GmbH (Dental Division)
Class III · Ongoing
Class III FDA medical device recall by Heraeus Medical GmbH (Dental Division), initiated 2026-03-25. FDA's recall record names no specific 510(k) clearance for this event. 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)..
- Recalling firm
- Heraeus Medical GmbH (Dental Division)
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2026-03-25
- Firm location
- Wehrheim, Germany
Product description
Heraeus, PALAMIX uno. Material Number: 66057893.
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.