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 high severity by Argus HQ. FDA published the underlying record on 2026-10-07; Argus observed and indexed it on 2026-10-13.

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 · high

Heraeus Medical GmbH (Dental Division) — Class II recall: PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287.…

Name: FDA Recall Record — Heraeus Medical GmbH (Dental Division)
Creator: Argus HQ
Published: 2026-10-07
License: https://argushq.ai/methodology

Event date: 2026-10-07 00:00:00Z
Observed: 2026-10-13 04:20:45Z
Source ID: Z-3301-2026
Payload hash: 1d48a231eafa9bcad4f6b56a…

Summary

Potential for monomer liquid leakage. 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 high severity by Argus HQ. FDA published the underlying record on 2026-10-07; Argus observed and indexed it on 2026-10-13.
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 II recall: PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287.…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-heraeus-medical-gmbh-dental-division-z-3301-2026

MLA

"Heraeus Medical GmbH (Dental Division) — Class II recall: PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287.…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-heraeus-medical-gmbh-dental-division-z-3301-2026.

Chicago

Argus HQ Research. "Heraeus Medical GmbH (Dental Division) — Class II recall: PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287.…." Digital Empire Holdings LLC. Accessed October 13, 2026. https://argushq.ai/events/fda-recall-heraeus-medical-gmbh-dental-division-z-3301-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_heraeus_medical_gmbh_dental_division_z_3301_2026_2026,
  title = {Heraeus Medical GmbH (Dental Division) — Class II recall: PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287.…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-heraeus-medical-gmbh-dental-division-z-3301-2026},
  note = {Accessed: October 13, 2026}
}

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