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.

.hq

fda_recall · device_recall · medium

Heraeus Medical GmbH (Dental Division) — Class III recall: Heraeus, PALAMIX duo. Material Number: 66057897.

Name: FDA Recall Record — Heraeus Medical GmbH (Dental Division)
Creator: Argus HQ
Published: 2026-05-06
License: https://argushq.ai/methodology

Event date: 2026-05-06 00:00:00Z
Observed: 2026-07-09 22:52:47Z
Source ID: Z-1998-2026
Payload hash: f86005027849ee94a81b7ac9…

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

Heraeus Medical GmbH (Dental Division)

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 duo. Material Number: 66057897.. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-heraeus-medical-gmbh-dental-division-z-1998-2026

MLA

"Heraeus Medical GmbH (Dental Division) — Class III recall: Heraeus, PALAMIX duo. Material Number: 66057897.." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-heraeus-medical-gmbh-dental-division-z-1998-2026.

Chicago

Argus HQ Research. "Heraeus Medical GmbH (Dental Division) — Class III recall: Heraeus, PALAMIX duo. Material Number: 66057897.." Digital Empire Holdings LLC. Accessed October 13, 2026. https://argushq.ai/events/fda-recall-heraeus-medical-gmbh-dental-division-z-1998-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_heraeus_medical_gmbh_dental_division_z_1998_2026_2026,
  title = {Heraeus Medical GmbH (Dental Division) — Class III recall: Heraeus, PALAMIX duo. Material Number: 66057897.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-heraeus-medical-gmbh-dental-division-z-1998-2026},
  note = {Accessed: October 13, 2026}
}

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