Skip to main content
Recall Canary
PALAMIX duo / PALAMIX uno
← Back to all recalls
MEDICAL DEVICE RECALLLOW

PALAMIX duo / PALAMIX uno

Heraeus recalls PALAMIX duo and uno mixing units due to risk of mixing rod loosening in units over 17 months old.

What to do

Check the material number on your PALAMIX unit. If the unit is older than 17 months, stop using it and contact Heraeus Medical GmbH (Dental Division) for a replacement or 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

Heraeus Medical GmbH (Dental Division) is recalling PALAMIX duo (Material Number 66057897) and PALAMIX uno (Material Number 66057893) because the mixing rod may come loose from its lock during mixing in units older than 17 months. 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.

ProductUPCRecall #
Heraeus, PALAMIX uno. Material Number: 66057893.66057893, 04260102133587Z-1997-2026
Heraeus, PALAMIX duo. Material Number: 66057897.66057897, 04260102133617Z-1998-2026

Where it was sold

Distributed nationwide.

← Back to all recalls

Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification