FDA action counts
| Total FDA actions | 4 |
|---|---|
| Warning letters | 0 |
| Recalls | 4 |
| Approval records | 0 |
| Form 483 inspection citations | 0 |
| Most recent action | April 29, 2026 |
Enforcement history
On 2026-04-29, Argus HQ recorded a FDA recall for Diversatek Healthcare, rated "high" severity in Argus HQ's classification: Diversatek Healthcare — Class II recall: Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-29, Argus HQ recorded a FDA recall for Diversatek Healthcare, rated "high" severity in Argus HQ's classification: Diversatek Healthcare — Class II recall: Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, RE… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-29, Argus HQ recorded a FDA recall for Diversatek Healthcare, rated "high" severity in Argus HQ's classification: Diversatek Healthcare — Class II recall: Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-29, Argus HQ recorded a FDA recall for Diversatek Healthcare, rated "high" severity in Argus HQ's classification: Diversatek Healthcare — Class II recall: Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, Diversatek Healthcare has 4 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).
Risk pattern analysis
Argus HQ analysis — not an FDA finding
This section is Argus HQ analysis, not an FDA finding. Diversatek Healthcare has 4 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. 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.
Frequently asked questions
- Does Argus HQ track new FDA actions for Diversatek Healthcare 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 Diversatek Healthcare is observed, this page's event count and history update automatically.
- How many FDA actions does Argus HQ track for Diversatek Healthcare?
- 4 total: 0 warning letters, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.
- What is the most recent FDA action on file for Diversatek Healthcare?
- April 29, 2026. Argus HQ ingests new FDA enforcement records daily.
- Has Diversatek Healthcare had product recalls?
- Yes, 4 recalls on file. See the full history below for each one.
Every FDA action tied to this company, the week it happens.
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Related enforcement actions
- Diversatek Healthcare — Class II recall: Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, RE… →
- Diversatek Healthcare — Class II recall: Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm… →
- Diversatek Healthcare — Class II recall: Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15… →
- Diversatek Healthcare — Class II recall: Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18… →
Compare with
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
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). Diversatek Healthcare — FDA Enforcement History. Digital Empire LLC. Retrieved from https://argushq.ai/company/diversatek-healthcare
"Diversatek Healthcare — FDA Enforcement History." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/company/diversatek-healthcare.
Argus HQ Research. "Diversatek Healthcare — FDA Enforcement History." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/company/diversatek-healthcare.
@misc{argushq_argushq_ai_company_diversatek_healthcare_2026,
title = {Diversatek Healthcare — FDA Enforcement History},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/company/diversatek-healthcare},
note = {Accessed: July 13, 2026}
}Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗

