What is the most recent FDA action on file for Bolton Medical Inc.?

June 3, 2026. Argus HQ ingests new FDA enforcement records daily.

Has Bolton Medical Inc. had product recalls?

Yes, 1 recall on file. See the full history below for each one.

Is this FDA enforcement data for Bolton Medical Inc. 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 Bolton Medical Inc. had?

Argus HQ has recorded 1 FDA events for Bolton Medical Inc.: 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.

FDA Enforcement History: Bolton Medical Inc.

Here's the summary: Argus HQ has recorded 1 FDA events for Bolton Medical Inc.: 0 warning letters, 1 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2026-06-03 to 2026-06-03. The most severe rating Argus HQ has assigned across this history is "critical". 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.

FDA action counts

Total FDA actions	1
Warning letters	0
Recalls	1
Approval records	0
Form 483 inspection citations	0
Most recent action	June 3, 2026

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Bolton Medical Inc. 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 2026-06-03, Argus HQ recorded an FDA recall for Bolton Medical Inc., rated "critical" severity in Argus HQ's classification: Bolton Medical Inc. — Class I recall: RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-3…. 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 Bolton Medical Inc.?: June 3, 2026. Argus HQ ingests new FDA enforcement records daily.
Has Bolton Medical Inc. had product recalls?: Yes, 1 recall on file. See the full history below for each one.
Is this FDA enforcement data for Bolton Medical Inc. 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 Bolton Medical Inc. had?: Argus HQ has recorded 1 FDA events for Bolton Medical Inc.: 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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Bolton Medical Inc. — Class I recall: RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-3… →

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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 Enforcement History: Bolton Medical Inc.. Digital Empire LLC. Retrieved from https://argushq.ai/company/bolton-medical-inc

MLA

"FDA Enforcement History: Bolton Medical Inc.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/company/bolton-medical-inc.

Chicago

Argus HQ Research. "FDA Enforcement History: Bolton Medical Inc.." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/company/bolton-medical-inc.

BibTeX

@misc{argushq_argushq_ai_company_bolton_medical_inc_2026,
  title = {FDA Enforcement History: Bolton Medical Inc.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/company/bolton-medical-inc},
  note = {Accessed: July 13, 2026}
}

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