FDA Device recall Z-1997-2026
Heraeus, PALAMIX uno
- FDA Device
- Class III
- ongoing
- Published 2026-05-06
On 2026-05-06 the FDA classified a Class III recall of Heraeus, PALAMIX uno by Heraeus Medical Dental Division, citing 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 mixin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1997-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-03-25 |
| Published | 2026-05-06 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Heraeus Medical Dental Division |
| Distribution | US |
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).
Identifiers
| code_info | Material Number: 66057893; UDI-DI: 04260102133587; Batch: all batches with numbers below 223060; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1997-2026%22
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