fda_recall · device_recall · medium
Heraeus Medical GmbH (Dental Division) — Class III recall: Heraeus, PALAMIX uno. Material Number: 66057893.
- Event date
- 2026-05-06 00:00:00Z
- Observed
- 2026-07-09 22:52:44Z
- Source ID
- Z-1997-2026
- Payload hash
- 0eb7a69b1b9b3b3583f0994e…
Summary
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). Status: Ongoing.
Informational only. Not legal, financial, or medical advice.