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FDAMarch 25, 2026device

Heraeus, PALAMIX uno. Material Number: 66057893.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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).

What to do

FDA enforcement status: Ongoing

Brands named

heraeus medical gmbh dental divisionheraeusheraeus medical

UPCs

04260102133587

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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