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fda_recall · device_recall · medium

Heraeus Medical GmbH (Dental Division) — Class III recall: Heraeus, PALAMIX uno. Material Number: 66057893.

Event date
2026-05-06 00:00:00Z
Observed
2026-07-09 22:52:44Z
Source ID
Z-1997-2026
Payload hash
0eb7a69b1b9b3b3583f0994e…

Summary

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). Status: Ongoing.

Entities

View source record ↗

Frequently asked questions

Has Heraeus Medical GmbH (Dental Division) had other FDA enforcement actions?
Yes. Argus HQ has recorded 6 total FDA actions tied to Heraeus Medical GmbH (Dental Division): 0 warning letters, 6 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?
This is an Argus HQ record of a FDA Recall, tagged medium severity by Argus HQ. FDA published the underlying record on 2026-05-06; Argus observed and indexed it on 2026-07-09.
Where can I verify this record directly with FDA?
The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA
Argus HQ Research (2026). Heraeus Medical GmbH (Dental Division) — Class III recall: Heraeus, PALAMIX uno. Material Number: 66057893.. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-heraeus-medical-gmbh-dental-division-z-1997-2026
MLA
"Heraeus Medical GmbH (Dental Division) — Class III recall: Heraeus, PALAMIX uno. Material Number: 66057893.." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-heraeus-medical-gmbh-dental-division-z-1997-2026.
Chicago
Argus HQ Research. "Heraeus Medical GmbH (Dental Division) — Class III recall: Heraeus, PALAMIX uno. Material Number: 66057893.." Digital Empire Holdings LLC. Accessed October 13, 2026. https://argushq.ai/events/fda-recall-heraeus-medical-gmbh-dental-division-z-1997-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_heraeus_medical_gmbh_dental_division_z_1997_2026_2026,
  title = {Heraeus Medical GmbH (Dental Division) — Class III recall: Heraeus, PALAMIX uno. Material Number: 66057893.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-heraeus-medical-gmbh-dental-division-z-1997-2026},
  note = {Accessed: October 13, 2026}
}

Informational only. Not legal, financial, or medical advice.

Heraeus Medical GmbH (Dental Division) — Class III recall: Heraeus, PALAMIX uno. Material Number: 66057893. · Argus HQ