PALAMIXRecalls & reported problems across all models

We found 2 models of PALAMIX by Heraeus Medical GmbH in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

PALAMIX recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 25, 2026Open, Classified

   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).

   Z-1998-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Mar 25, 2026Open, Classified

   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).

   Z-1997-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

PALAMIX models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PALAMIX® UNO

  Mixer, Cement, For Clinical Use
  1 recall0 reports
• PALAMIX® DUO

  Mixer, Cement, For Clinical Use
  1 recall0 reports

Other Heraeus Medical GmbH products

• PALACOS8 models · 2 reports · 8 recalls