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Heraeus PALAMIX uno Mixing System
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MEDICAL DEVICE RECALLLOW

Heraeus PALAMIX uno Mixing System

Heraeus is reducing the shelf life of the PALAMIX uno mixing system to 17 months due to a potential mixing rod detachment issue.

What to do

Check the expiration date on your product. If the unit is older than 17 months, discontinue use and contact Heraeus Medical for further instructions.

Posted
Updated
Recall No.
Z-1997-2026
Agency
Firm
Heraeus Medical GmbH (Dental Division)
Recall ID
98608
Status
ONGOING

Why it was recalled

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).

How to identify it

UPC 66057893 04260102133587

Heraeus, PALAMIX uno. Material Number: 66057893.

Where it was sold

Distributed in US.

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Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification