Official recall record

Heraeus, PALAMIX duo. Material Number: 66057897.

US FDA — Medical Devices · 2026-03-25 · GermanyClass III

Issuing authority: US FDA — Medical Devices
Alert date: 2026-03-25
Country of alert: Germany
Alert level: Class III
Alert type: recall
Brand on record: Heraeus Medical GmbH (Dental Division)

What the authority reported

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

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · Germany · all filters

Other recalls from this brand

2026-03-25 · US FDA — Medical Devices
Heraeus, PALAMIX uno. Material Number: 66057893.

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.