What is the most recent FDA action against Heraeus Medical GmbH (Dental Division)?

The most recent FDA event Argus HQ has on file for Heraeus Medical GmbH (Dental Division) is dated 2026-05-06, with a severity rating of "medium" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Does Argus HQ track new FDA actions for Heraeus Medical GmbH (Dental Division) automatically?

Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Heraeus Medical GmbH (Dental Division) is observed, this page's event count and history update automatically.

How many FDA actions does Argus HQ track for Heraeus Medical GmbH (Dental Division)?

2 total: 0 warning letters, 2 recalls, 0 approval records, and 0 Form 483 inspection citations.

What is the most recent FDA action on file for Heraeus Medical GmbH (Dental Division)?

May 6, 2026. Argus HQ ingests new FDA enforcement records daily.

FDA Actions Against Heraeus Medical GmbH (Dental Division)

Argus HQ has recorded 2 FDA events for Heraeus Medical GmbH (Dental Division): 0 warning letters, 2 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2026-05-06 to 2026-05-06. The most severe rating Argus HQ has assigned across this history is "medium". Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

FDA action counts

Total FDA actions	2
Warning letters	0
Recalls	2
Approval records	0
Form 483 inspection citations	0
Most recent action	May 6, 2026

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Heraeus Medical GmbH (Dental Division) has 2 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

Enforcement history

On 2026-05-06, Argus HQ recorded a FDA recall for Heraeus Medical GmbH (Dental Division), rated "medium" severity in Argus HQ's classification: Heraeus Medical GmbH (Dental Division) — Class III recall: Heraeus, PALAMIX uno. Material Number: 66057893. An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-06, Argus HQ recorded a FDA recall for Heraeus Medical GmbH (Dental Division), rated "medium" severity in Argus HQ's classification: Heraeus Medical GmbH (Dental Division) — Class III recall: Heraeus, PALAMIX duo. Material Number: 66057897. An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, Heraeus Medical GmbH (Dental Division) has 2 FDA events on file with Argus HQ across the sources Argus HQ currently tracks (FDA Warning Letters, recalls, drug/biologic approvals, and Form 483 inspection observations). Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Counting an FDA record here does not by itself indicate an unresolved problem -- warning letters, recalls, and inspection observations are frequently closed out once a firm completes FDA-required corrective action.

Frequently asked questions

What is the most recent FDA action against Heraeus Medical GmbH (Dental Division)?: The most recent FDA event Argus HQ has on file for Heraeus Medical GmbH (Dental Division) is dated 2026-05-06, with a severity rating of "medium" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
Does Argus HQ track new FDA actions for Heraeus Medical GmbH (Dental Division) automatically?: Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Heraeus Medical GmbH (Dental Division) is observed, this page's event count and history update automatically.
How many FDA actions does Argus HQ track for Heraeus Medical GmbH (Dental Division)?: 2 total: 0 warning letters, 2 recalls, 0 approval records, and 0 Form 483 inspection citations.
What is the most recent FDA action on file for Heraeus Medical GmbH (Dental Division)?: May 6, 2026. Argus HQ ingests new FDA enforcement records daily.

Every FDA action tied to this company, the week it happens.

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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). FDA Actions Against Heraeus Medical GmbH (Dental Division). Digital Empire LLC. Retrieved from https://argushq.ai/company/heraeus-medical-gmbh-dental-division

MLA

"FDA Actions Against Heraeus Medical GmbH (Dental Division)." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/company/heraeus-medical-gmbh-dental-division.

Chicago

Argus HQ Research. "FDA Actions Against Heraeus Medical GmbH (Dental Division)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/company/heraeus-medical-gmbh-dental-division.

BibTeX

@misc{argushq_argushq_ai_company_heraeus_medical_gmbh_dental_division_2026,
  title = {FDA Actions Against Heraeus Medical GmbH (Dental Division)},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/company/heraeus-medical-gmbh-dental-division},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗