Consumer Alerts TrackerIndependent U.S. recall decision aid
How it works Search recalls
Limited official informationFDA Medical Device Enforcement ReportsRecall date: May 6, 2026

Heraeus, PALAMIX uno. Material Number: 66057893.

Full official product description

Heraeus, PALAMIX uno. Material Number: 66057893. | Heraeus, PALAMIX duo. Material Number: 66057897.

Verification delayed

The last verified facts remain visible. Last successful verification: Aug 2, 2026, 9:43 AM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

Missing: action, consumer scope. The page is public for lookup but excluded from search indexing and advertising.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

Heraeus, PALAMIX uno. Material Number: 66057893.; Heraeus, PALAMIX duo. Material Number: 66057897.

Identifiers to compare

  • UDI 04260102133587
  • UDI 04260102133617
Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
Heraeus, PALAMIX uno. Material Number: 66057893.Material Number: 66057893; UDI-DI: 04260102133587; Batch: all batches with numbers below 223060;51,771 unitsZ-1997-2026
Heraeus, PALAMIX duo. Material Number: 66057897.Material Number: 66057897; UDI-DI: 04260102133617; Batch: all batches with numbers below 520215;1,125 unitsZ-1998-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

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).

Agency classification: Class III

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

Worldwide distribution - US Nationwide and the countries of Aland Islands, Algeria, Australia, Austria, Belgium, Brazil , Chile, China, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Kosovo, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Netherlands, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Rep. of Korea, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom, Uruguay, Utd.Arab Emir.;

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

  • : affectedSummary changed in the official record.