FDA action counts
| Total FDA actions | 1 |
|---|---|
| Warning letters | 0 |
| Recalls | 1 |
| Approval records | 0 |
| Form 483 inspection citations | 0 |
| Most recent action | August 19, 2026 |
Risk pattern analysis
Argus HQ analysis — not an FDA finding
This section is Argus HQ analysis, not an FDA finding. Waldemar Link GmbH & Co. KG (Mfg Site) has 1 FDA event on file. 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. 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. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
Enforcement history
On 2026-08-19, Argus HQ recorded an FDA recall for Waldemar Link GmbH & Co. KG (Mfg Site), rated "high" severity in Argus HQ's classification: Waldemar Link GmbH & Co. KG (Mfg Site) — Class II recall: Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rota…. 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 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 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 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.
Frequently asked questions
- What is the most recent FDA action on file for Waldemar Link GmbH & Co. KG (Mfg Site)?
- August 19, 2026. Argus HQ ingests new FDA enforcement records daily.
- Has Waldemar Link GmbH & Co. KG (Mfg Site) had product recalls?
- Yes, 1 recall on file. See the full history below for each one.
- Is this FDA enforcement data for Waldemar Link GmbH & Co. KG (Mfg Site) official?
- Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.
- How many FDA actions has Waldemar Link GmbH & Co. KG (Mfg Site) had?
- Argus HQ has recorded 1 FDA events for Waldemar Link GmbH & Co. KG (Mfg Site): 0 warning letters, 1 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
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Related enforcement actions
Compare with
- Waldemar Link GmbH & Co. KG (Mfg Site) vs Philips North America
- Waldemar Link GmbH & Co. KG (Mfg Site) vs Medline Industries, LP
- Waldemar Link GmbH & Co. KG (Mfg Site) vs Boston Scientific Corporation
- Waldemar Link GmbH & Co. KG (Mfg Site) vs Baxter Healthcare Corporation
- Waldemar Link GmbH & Co. KG (Mfg Site) vs PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Two different companies merged onto this page by mistake? Or a name variant missing? Tell us — corrections@argushq.ai
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Verified from FDA.gov · Last updated: Aug 19, 2026Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). Waldemar Link GmbH & Co. KG (Mfg Site)'s Complete FDA Record. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/company/waldemar-link-gmbh-and-co-kg-mfg-site
"Waldemar Link GmbH & Co. KG (Mfg Site)'s Complete FDA Record." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/company/waldemar-link-gmbh-and-co-kg-mfg-site.
Argus HQ Research. "Waldemar Link GmbH & Co. KG (Mfg Site)'s Complete FDA Record." Digital Empire Holdings LLC. Accessed August 27, 2026. https://argushq.ai/company/waldemar-link-gmbh-and-co-kg-mfg-site.
@misc{argushq_argushq_ai_company_waldemar_link_gmbh_and_co_kg_mfg_site_2026,
title = {Waldemar Link GmbH & Co. KG (Mfg Site)'s Complete FDA Record},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/company/waldemar-link-gmbh-and-co-kg-mfg-site},
note = {Accessed: August 27, 2026}
}Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗

