PALAMIX uno Mixing Unit
Heraeus recalls PALAMIX uno mixing units: mixing rod may loosen in units over 17 months old; shelf life reduced to 1.5 years.
Check the age of your PALAMIX uno unit. If it is older than 17 months, stop using it and contact Heraeus Medical GmbH for a replacement or further instructions.
Why it was recalled
Heraeus Medical GmbH is recalling the PALAMIX uno mixing unit (Material Number 66057893) because long-term stability testing 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. The shelf life is being reduced from 3 years to 1.5 years (17 months).
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | Recall # | UDI-DI |
|---|---|---|
| Heraeus, PALAMIX uno. Material Number: 66057893. | Z-1997-2026 | 66057893, 04260102133587 |
| Heraeus, PALAMIX duo. Material Number: 66057897. | Z-1998-2026 | 66057897, 04260102133617 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Editorial summary by Recall Canary · summary updated 2026-09-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification