Reported May 6, 2026 · Ongoing
Heraeus, PALAMIX duo. Material Number: 66057897.
Heraeus Medical GmbH (Dental Division)
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Heraeus Medical GmbH (Dental Division) · Philipp-Reis-Str. 8 · Wehrheim · N/A
Is this the product you have?
- Heraeus, PALAMIX duo
- Material Number66057897
- Lot codes and dates
- Material Number66057897
- UDI-DI04260102133617
- Batchall batches with numbers below 520215
- Amount recalled
- 1,125 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
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).
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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